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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Biocon Limited

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    Biocon
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    Country
    Country
    India
    Address
    Address
    20th KM, Hosur Road,Electronics City,Bangalore
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    Telephone
    +91 80 2808 2808 / 91 80 4014 4014
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    Email
    enquiries@pharmacompass.com
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    https://www.biocon.com/
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    Fluvastatin Sodium

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    USDMF

    Found USDMF

    18493
    Active
    FLUVASTATIN SODIUM AMORPHOUS
    2005-07-07
    CEP/COS

    Found CEP/COS

    CEP 2018-182 - Rev 02
    Valid
    Fluvastatin sodium, Crystalline
    2024-03-25
    Japanese DMF

    Found JDMF

    225MF10102
    Fluvastatin sodium at 20th K. M. Ho...
    2013-05-13
    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Fluvastatin Sodium (EP)
    2022-04-13
    Application Number
    18493
    CEP 2018-182 - Rev 02
    225MF10102
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUVASTATIN SODIUM AMORPHOUS
    Fluvastatin sodium, Crystalline
    Fluvastatin sodium at 20th K. M. Ho...
    Fluvastatin Sodium (EP)
    Issue/Submission Date
    2005-07-07
    2024-03-25
    2013-05-13
    2022-04-13
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    Pravastatin

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    USDMF

    Found USDMF

    16048
    Active
    PRAVASTATIN SODIUM USP
    2002-07-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-177 - Rev 02
    Valid
    Pravastatin sodium
    2013-06-13
    Japanese DMF

    Found JDMF

    223MF10038
    Pravastatin sodium at 20th KM Hosur...
    2011-03-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Pravastatin Sodium (EP)
    2022-04-13
    Application Number
    16048
    R1-CEP 2002-177 - Rev 02
    223MF10038
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PRAVASTATIN SODIUM USP
    Pravastatin sodium
    Pravastatin sodium at 20th KM Hosur...
    Pravastatin Sodium (EP)
    Issue/Submission Date
    2002-07-12
    2013-06-13
    2011-03-10
    2022-04-13
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    • FDA
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    Repaglinide

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    USDMF

    Found USDMF

    18482
    Active
    REPAGLINIDE
    2005-07-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-093 - Rev 01
    Valid
    Repaglinide
    2018-08-20
    Japanese DMF

    Found JDMF

    231MF10044
    Repaglinide at 20th K. M. Hosur Roa...
    2019-02-13
    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Repaglinide (EP/USP)
    2022-04-13
    Application Number
    18482
    R1-CEP 2008-093 - Rev 01
    231MF10044
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    REPAGLINIDE
    Repaglinide
    Repaglinide at 20th K. M. Hosur Roa...
    Repaglinide (EP/USP)
    Issue/Submission Date
    2005-07-06
    2018-08-20
    2019-02-13
    2022-04-13
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    • FDA
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    Atorvastatin

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    USDMF

    Caution USDMF

    20207
    Inactive
    ATORVASTATIN MAGNESIUM
    2007-01-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-009 - Rev 03
    Valid
    Atorvastatin calcium, Crystalline
    2022-12-08
    Japanese DMF

    Found JDMF

    229MF10178
    Atorvastatin calcium hydrate at 20t...
    2017-09-15
    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Atorvastatin Calcium Trihydrate (EP...
    2022-04-13
    Application Number
    20207
    R1-CEP 2011-009 - Rev 03
    229MF10178
    Indian CDSCO WC-0109
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ATORVASTATIN MAGNESIUM
    Atorvastatin calcium, Crystalline
    Atorvastatin calcium hydrate at 20t...
    Atorvastatin Calcium Trihydrate (EP...
    Issue/Submission Date
    2007-01-16
    2022-12-08
    2017-09-15
    2022-04-13
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    Pravastatin

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    USDMF

    Found USDMF

    17447
    Active
    PRAVASTATIN SODIUM
    2004-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-085 - Rev 05
    Valid
    Pravastatin sodium, Product Code 80...
    2020-05-14
    Japanese DMF

    Found JDMF

    223MF10039
    Pravastatin sodium at 20th K. M. Ho...
    2011-03-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Pravastatin Sodium (Ph.Eur)
    2019-07-22
    Application Number
    17447
    R1-CEP 2004-085 - Rev 05
    223MF10039
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PRAVASTATIN SODIUM
    Pravastatin sodium, Product Code 80...
    Pravastatin sodium at 20th K. M. Ho...
    Pravastatin Sodium (Ph.Eur)
    Issue/Submission Date
    2004-06-03
    2020-05-14
    2011-03-10
    2019-07-22
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    Mycophenolate Mofetil

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    USDMF

    Found USDMF

    16406
    Active
    MYCOPHENOLATE MOFETIL
    2003-01-20
    CEP/COS

    Found CEP/COS

    CEP 2010-162 - Rev 08
    Valid
    Mycophenolate mofetil, Process II
    2024-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Mycophenolate Mofetil (EP)
    2022-04-13
    Application Number
    16406
    CEP 2010-162 - Rev 08
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MYCOPHENOLATE MOFETIL
    Mycophenolate mofetil, Process II
    Mycophenolate Mofetil (EP)
    Issue/Submission Date
    2003-01-20
    2024-01-04
    2022-04-13
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    Mycophenolate Sodium

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    USDMF

    Found USDMF

    23519
    Active
    MYCOPHENOLATE SODIUM
    2010-02-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-019 - Rev 00
    Valid
    Mycophenolate sodium
    2023-06-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Mycophenolate Sodium
    2022-04-13
    Application Number
    23519
    R0-CEP 2022-019 - Rev 00
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MYCOPHENOLATE SODIUM
    Mycophenolate sodium
    Mycophenolate Sodium
    Issue/Submission Date
    2010-02-08
    2023-06-06
    2022-04-13
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    26540
    Active
    ROSUVASTATIN CALCIUM
    2012-10-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-040 - Rev 00
    Valid
    Rosuvastatin calcium
    2020-12-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Rosuvastatin Calcium
    2022-04-13
    Application Number
    26540
    R1-CEP 2015-040 - Rev 00
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Rosuvastatin Calcium
    Issue/Submission Date
    2012-10-11
    2020-12-10
    2022-04-13
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    • FDA
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    Tacrolimus

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    USDMF

    Found USDMF

    18442
    Active
    TACROLIMUS USP
    2005-06-21
    CEP/COS

    Found CEP/COS

    CEP 2017-257 - Rev 01
    Valid
    Tacrolimus monohydrate
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Tacrolimus, (USP)/Tacrolimus Monohy...
    2022-04-13
    Application Number
    18442
    CEP 2017-257 - Rev 01
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    TACROLIMUS USP
    Tacrolimus monohydrate
    Tacrolimus, (USP)/Tacrolimus Monohy...
    Issue/Submission Date
    2005-06-21
    2023-11-29
    2022-04-13
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    • FDA
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    Deferasirox

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    USDMF

    Found USDMF

    28626
    Active
    DEFERASIROX
    2015-01-02
    CEP/COS

    Found CEP/COS

    CEP 2022-080 - Rev 00
    Valid
    Deferasirox
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Deferasirox IH
    2019-09-09
    Application Number
    28626
    CEP 2022-080 - Rev 00
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-04
    Filing Details
    DEFERASIROX
    Deferasirox
    Deferasirox IH
    Issue/Submission Date
    2015-01-02
    2024-03-20
    2019-09-09
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    • FDA
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    Everolimus

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    USDMF

    Found USDMF

    29651
    Active
    EVEROLIMUS (WITH 0.2% BHT)
    2015-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-235 - Rev 00
    Valid
    Everolimus, 0.2% BHT-II
    2022-08-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Everolimus (IH)
    2019-07-22
    Application Number
    29651
    R0-CEP 2022-235 - Rev 00
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    EVEROLIMUS (WITH 0.2% BHT)
    Everolimus, 0.2% BHT-II
    Everolimus (IH)
    Issue/Submission Date
    2015-09-30
    2022-08-26
    2019-07-22
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    Everolimus

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    USDMF

    Found USDMF

    29657
    Active
    EVEROLIMUS
    2015-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-143 - Rev 00
    Valid
    Everolimus, 2% BHT-II
    2022-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100A7
    Expired
    Everolimus EP
    2020-08-17
    Application Number
    29657
    R0-CEP 2022-143 - Rev 00
    Indian CDSCO WC-0100A7
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    EVEROLIMUS
    Everolimus, 2% BHT-II
    Everolimus EP
    Issue/Submission Date
    2015-09-30
    2022-08-31
    2020-08-17
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    • FDA
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    Micafungin

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    USDMF

    Found USDMF

    30880
    Active
    MICAFUNGIN SODIUM
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10166
    MICAFUNGIN SODIUM at 20th KM, Hosur...
    2018-12-10
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    MICAFUNGIN SODIUM IH
    2019-07-22
    Application Number
    30880
    230MF10166
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MICAFUNGIN SODIUM
    MICAFUNGIN SODIUM at 20th KM, Hosur...
    MICAFUNGIN SODIUM IH
    Issue/Submission Date
    2016-09-30
    2018-12-10
    2019-07-22
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    Pioglitazone Hydrochloride

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    USDMF

    Found USDMF

    16635
    Active
    PIOGLITAZONE HYDROCHLORIDE USP
    2003-06-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-340 - Rev 00
    Valid
    Pioglitazone hydrochloride
    2018-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Pioglitazone Hydrochloride (IH)
    2019-07-22
    Application Number
    16635
    R1-CEP 2012-340 - Rev 00
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE USP
    Pioglitazone hydrochloride
    Pioglitazone Hydrochloride (IH)
    Issue/Submission Date
    2003-06-11
    2018-10-31
    2019-07-22
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    27675
    Active
    ROSUVASTATIN CALCIUM (PRODUCT CODE ...
    2013-10-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-114 - Rev 02
    Valid
    Rosuvastatin calcium, Process I
    2023-01-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Rosuvastatin Calcium IH/USP/EP
    2019-09-09
    Application Number
    27675
    R1-CEP 2015-114 - Rev 02
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-04
    Filing Details
    ROSUVASTATIN CALCIUM (PRODUCT CODE ...
    Rosuvastatin calcium, Process I
    Rosuvastatin Calcium IH/USP/EP
    Issue/Submission Date
    2013-10-08
    2023-01-27
    2019-09-09
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    Simvastatin

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    USDMF

    Found USDMF

    18449
    Active
    SIMVASTATIN
    2005-06-23
    CEP/COS

    Found CEP/COS

    CEP 2012-337 - Rev 03
    Valid
    Simvastatin
    2024-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Simvastatin (Ph.Eur/USP)
    2019-07-22
    Application Number
    18449
    CEP 2012-337 - Rev 03
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    SIMVASTATIN
    Simvastatin
    Simvastatin (Ph.Eur/USP)
    Issue/Submission Date
    2005-06-23
    2024-01-26
    2019-07-22
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    Simvastatin

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    USDMF

    Caution USDMF

    16094
    Inactive
    SIMVASTATIN USP
    2002-08-12
    CEP/COS

    Found CEP/COS

    CEP 2003-131 - Rev 12
    Valid
    Simvastatin, Butylated Hydroxyaniso...
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Simvastatin (EP/USP)
    2022-04-13
    Application Number
    16094
    CEP 2003-131 - Rev 12
    Indian CDSCO WC-0109
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    SIMVASTATIN USP
    Simvastatin, Butylated Hydroxyaniso...
    Simvastatin (EP/USP)
    Issue/Submission Date
    2002-08-12
    2023-11-08
    2022-04-13
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    33143
    Active
    SITAGLIPTIN PHOSPHATE
    2018-09-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-197 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2023-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100-A5
    Expired
    Sitagliptin Phosphate IH/USP
    2020-01-28
    Application Number
    33143
    R0-CEP 2020-197 - Rev 00
    Indian CDSCO WC-0100-A5
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    SITAGLIPTIN PHOSPHATE
    Sitagliptin phosphate monohydrate
    Sitagliptin Phosphate IH/USP
    Issue/Submission Date
    2018-09-28
    2023-08-11
    2020-01-28
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    Vildagliptin

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    USDMF

    Found USDMF

    39122
    Active
    VILDAGLIPTIN
    2023-11-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10035
    Vildagliptin at 20th K. M. Hosur Ro...
    2022-02-17
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Vildagliptin IH
    2019-07-22
    Application Number
    39122
    304MF10035
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    VILDAGLIPTIN
    Vildagliptin at 20th K. M. Hosur Ro...
    Vildagliptin IH
    Issue/Submission Date
    2023-11-10
    2022-02-17
    2019-07-22
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    Everolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31950
    Active
    EVEROLIMUS (2% BHT)
    2018-05-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-323 - Rev 00
    Valid
    Everolimus, 0.2% BHT
    2022-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31950
    R0-CEP 2019-323 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS (2% BHT)
    Everolimus, 0.2% BHT
    Issue/Submission Date
    2018-05-02
    2022-01-31
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    Everolimus

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    35688
    Active
    EVEROLIMUS PREMIX 2%
    2021-04-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-072 - Rev 01
    Valid
    Everolimus, 2% BHT
    2023-04-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35688
    R0-CEP 2020-072 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS PREMIX 2%
    Everolimus, 2% BHT
    Issue/Submission Date
    2021-04-01
    2023-04-19
    ASK
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    • FDA
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    Fingolimod Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28276
    Active
    FINGOLIMOD HYDROCHLORIDE
    2014-06-11
    CEP/COS

    Found CEP/COS

    CEP 2020-156 - Rev 02
    Valid
    Fingolimod hydrochloride
    2023-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28276
    CEP 2020-156 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE
    Fingolimod hydrochloride
    Issue/Submission Date
    2014-06-11
    2023-09-15
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    • FDA
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    Fluvastatin Sodium

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    18762
    Active
    FLUVASTATIN SODIUM
    2005-09-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-130 - Rev 01
    Valid
    Fluvastatin sodium, Crystalline-2
    2022-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18762
    R0-CEP 2022-130 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUVASTATIN SODIUM
    Fluvastatin sodium, Crystalline-2
    Issue/Submission Date
    2005-09-13
    2022-06-23
    ASK
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    Fluvastatin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36735
    Active
    FLUVASTATIN SODIUM
    2022-02-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-139 - Rev 01
    Valid
    Fluvastatin sodium, Amorphous-2
    2022-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36735
    R0-CEP 2022-139 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FLUVASTATIN SODIUM
    Fluvastatin sodium, Amorphous-2
    Issue/Submission Date
    2022-02-28
    2022-08-08
    ASK
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    • FDA
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    Insulin Glargine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27093
    Active
    INSULIN GLARGINE (RDNA ORIGIN)
    2013-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10213
    Insulin glargine (gene recombinatio...
    2014-11-17
    Written Confirmation

    Close WC

    Application Number
    27093
    226MF10213
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INSULIN GLARGINE (RDNA ORIGIN)
    Insulin glargine (gene recombinatio...
    Issue/Submission Date
    2013-05-24
    2014-11-17
    ASK
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    Lovastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    14912
    Active
    LOVASTATIN USP
    2000-06-05
    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-354 - Rev 02
    Withdrawn by Holder
    Lovastatin
    2004-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Lovastatin (Ph.Eur
    2019-07-22
    Application Number
    14912
    R0-CEP 2001-354 - Rev 02
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-02
    Filing Details
    LOVASTATIN USP
    Lovastatin
    Lovastatin (Ph.Eur
    Issue/Submission Date
    2000-06-05
    2004-10-11
    2019-07-22
    ASK
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    your Marketing & Sales content
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    • FDA
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    Pimecrolimus

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29390
    Active
    PIMECROLIMUS
    2015-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Pimecrolimus
    2022-04-13
    Application Number
    29390
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PIMECROLIMUS
    Pimecrolimus
    Issue/Submission Date
    2015-09-30
    2022-04-13
    ASK
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    • FDA
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    Pioglitazone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23278
    Active
    PIOGLITAZONE HYDROCHLORIDE USP
    2009-11-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-351 - Rev 00
    Valid
    Pioglitazone hydrochloride, Process...
    2021-09-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23278
    R1-CEP 2014-351 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PIOGLITAZONE HYDROCHLORIDE USP
    Pioglitazone hydrochloride, Process...
    Issue/Submission Date
    2009-11-16
    2021-09-23
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35387
    Active
    RIVAROXABAN USP
    2020-12-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-144 - Rev 00
    Valid
    Rivaroxaban
    2023-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35387
    R0-CEP 2022-144 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVAROXABAN USP
    Rivaroxaban
    Issue/Submission Date
    2020-12-31
    2023-07-20
    ASK
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    • FDA
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    Sirolimus

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    21571
    Active
    SIROLIMUS DRUG SUBSTANCE
    2008-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0109
    Valid
    Sirolimus
    2022-04-13
    Application Number
    21571
    Indian CDSCO WC-0109
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    SIROLIMUS DRUG SUBSTANCE
    Sirolimus
    Issue/Submission Date
    2008-04-16
    2022-04-13
    ASK
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    • FDA
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    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35388
    Active
    APIXABAN
    2020-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038A2
    Expired
    Apixaban IHS
    2022-02-18
    Application Number
    35388
    Indian CDSCO WC-0038A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    APIXABAN
    Apixaban IHS
    Issue/Submission Date
    2020-12-31
    2022-02-18
    ASK
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    • FDA
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    Atorvastatin

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    25247
    Active
    ATORVASTATIN CALCIUM (USP) CRYSTALL...
    2011-08-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Atorvastatin Magnesium (IH)
    2019-07-22
    Application Number
    25247
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ATORVASTATIN CALCIUM (USP) CRYSTALL...
    Atorvastatin Magnesium (IH)
    Issue/Submission Date
    2011-08-26
    2019-07-22
    ASK
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    your Marketing & Sales content
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    • FDA
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    Brinzolamide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    28933
    Active
    BRINZOLAMIDE USP (STERILIZED)
    2015-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038A2
    Expired
    Brinzolamide USP
    2022-02-18
    Application Number
    28933
    Indian CDSCO WC-0038A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    BRINZOLAMIDE USP (STERILIZED)
    Brinzolamide USP
    Issue/Submission Date
    2015-09-25
    2022-02-18
    ASK
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    • FDA
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    Dabigatran Etexilate Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    33112
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2018-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Dabigatran etexilate mesilate IH
    2019-09-09
    Application Number
    33112
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Dabigatran etexilate mesilate IH
    Issue/Submission Date
    2018-09-28
    2019-09-09
    ASK
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    your Marketing & Sales content
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    • FDA
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    Dapagliflozin

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    31762
    Active
    DAPAGLIFLOZIN
    2017-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Dapagliflozin IH
    2019-09-09
    Application Number
    31762
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    DAPAGLIFLOZIN
    Dapagliflozin IH
    Issue/Submission Date
    2017-07-03
    2019-09-09
    ASK
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    • FDA
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    Dapagliflozin Propanediol Monohydrate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35928
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2021-07-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038A2
    Expired
    Dapagliflozin Propanediol IHS
    2022-02-18
    Application Number
    35928
    Indian CDSCO WC-0038A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Dapagliflozin Propanediol IHS
    Issue/Submission Date
    2021-07-05
    2022-02-18
    ASK
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    your Marketing & Sales content
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    • FDA
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    Lenalidomide

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    34956
    Active
    LENALIDOMIDE
    2020-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0405A2
    Expired
    Lenalidomide IHS
    2021-05-28
    Application Number
    34956
    Indian CDSCO WC-0405A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-03-14
    Filing Details
    LENALIDOMIDE
    Lenalidomide IHS
    Issue/Submission Date
    2020-07-31
    2021-05-28
    ASK
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    • FDA
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    Linagliptin

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35771
    Active
    LINAGLIPTIN
    2021-06-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Linagliptin IH
    2019-09-09
    Application Number
    35771
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    LINAGLIPTIN
    Linagliptin IH
    Issue/Submission Date
    2021-06-01
    2019-09-09
    ASK
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    your Marketing & Sales content
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    • FDA
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    Mirabegron

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    35117
    Active
    MIRABEGRON
    2020-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100A8
    Expired
    Mirabegron IH
    2021-01-15
    Application Number
    35117
    Indian CDSCO WC-0100A8
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MIRABEGRON
    Mirabegron IH
    Issue/Submission Date
    2020-09-30
    2021-01-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Mycophenolate Mofetil

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-052 - Rev 00
    Valid
    Mycophenolate mofetil
    2013-07-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0405
    Expired
    Mycophenolate Mofetil IP/USP/EP/BP/...
    2019-09-03
    Application Number
    R1-CEP 2007-052 - Rev 00
    Indian CDSCO WC-0405
    Status
    Valid
     
    Expired
    2022-03-14
    Filing Details
    Mycophenolate mofetil
    Mycophenolate Mofetil IP/USP/EP/BP/...
    Issue/Submission Date
    2013-07-09
    2019-09-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Orlistat

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    38096
    Active
    ORLISTAT USP
    2023-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Orlistat (IH/USP)
    2019-07-22
    Application Number
    38096
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ORLISTAT USP
    Orlistat (IH/USP)
    Issue/Submission Date
    2023-04-12
    2019-07-22
    ASK
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    your Marketing & Sales content
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    • FDA
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    Posaconazole

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    32524
    Active
    POSACONAZOLE
    2018-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0038
    Expired
    Posaconazole IH
    2019-09-09
    Application Number
    32524
    Indian CDSCO WC-0038
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    POSACONAZOLE
    Posaconazole IH
    Issue/Submission Date
    2018-03-29
    2019-09-09
    ASK
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    your Marketing & Sales content
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    • FDA
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    Temsirolimus

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    28841
    Active
    TEMSIROLIMUS
    2015-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0100
    Expired
    Temsirolimus (IH)
    2019-07-22
    Application Number
    28841
    Indian CDSCO WC-0100
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    TEMSIROLIMUS
    Temsirolimus (IH)
    Issue/Submission Date
    2015-01-22
    2019-07-22
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    Hydroxy Echinocandin

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    USDMF

    Found USDMF

    25728
    Active
    HYDROXY ECHINOCANDIN
    2011-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    25728
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDROXY ECHINOCANDIN
    Issue/Submission Date
    2011-01-19
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    Immunomycin

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    USDMF

    Found USDMF

    29442
    Active
    DRUG SUBSTANCE INTERMEDIATE IMMUNOM...
    2015-09-28
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29442
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DRUG SUBSTANCE INTERMEDIATE IMMUNOM...
    Issue/Submission Date
    2015-09-28
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    Insulin Lispro

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    USDMF

    Found USDMF

    23892
    Active
    HUMAN INSULIN-BULK (RDNA ORIGIN) (A...
    2010-06-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23892
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HUMAN INSULIN-BULK (RDNA ORIGIN) (A...
    Issue/Submission Date
    2010-06-07
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    Mevastatin

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    USDMF

    Found USDMF

    16049
    Active
    COMPACTIN
    2002-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    16049
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPACTIN
    Issue/Submission Date
    2002-07-12
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    Tacrolimus

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    USDMF

    Found USDMF

    23365
    Active
    TACROLIMUS (PRODUCT CODE 8000255)
    2009-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    23365
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TACROLIMUS (PRODUCT CODE 8000255)
    Issue/Submission Date
    2009-12-08
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    Tacrolimus

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    USDMF

    Found USDMF

    29786
    Active
    TACROLIMUS GRANULES 20% W/W
    2015-09-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    29786
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TACROLIMUS GRANULES 20% W/W
    Issue/Submission Date
    2015-09-24
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    Travoprost

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    USDMF

    Found USDMF

    25703
    Active
    TRAVOPROST USP DRUG SUBSTANCE
    2012-04-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25703
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRAVOPROST USP DRUG SUBSTANCE
    Issue/Submission Date
    2012-04-09
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