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    01 Albiglutide (1)

    02 Anidulafungin (1)

    03 Apixaban (1)

    04 Atorvastatin (4)

    05 Boron (1)

    06 Brinzolamide (1)

    07 CAS 654671-77-9 (1)

    08 Carfilzomib (1)

    09 Caspofungin (1)

    10 Colesevelam Hydrochloride (1)

    11 Dabigatran Etexilate Mesylate (1)

    12 Dalbavancin (1)

    13 Dapagliflozin (1)

    14 Dapagliflozin Propanediol Monohydrate (1)

    15 Daptomycin (1)

    16 Dasatinib (1)

    17 Deferasirox (1)

    18 Empagliflozin (1)

    19 Everolimus (4)

    20 Fidaxomicin (2)

    21 Fingolimod Hydrochloride (1)

    22 Fluvastatin Sodium (4)

    23 Glatiramer Acetate (1)

    24 Heparin Sodium (1)

    25 Hydroxy Echinocandin (1)

    26 Icatibant Acetate (1)

    27 Immunomycin (1)

    28 Insulin Glargine (1)

    29 Insulin Lispro (4)

    30 Ivabradine Hydrochloride (1)

    31 Lanreotide Acetate (1)

    32 Latanoprost (1)

    33 Lenalidomide (1)

    34 Linaclotide (1)

    35 Linagliptin (1)

    36 Liraglutide (1)

    37 Lovastatin (2)

    38 Mevastatin (1)

    39 Micafungin (2)

    40 Mirabegron (1)

    41 Mycophenolate Mofetil (2)

    42 Mycophenolate Sodium (2)

    43 Mycophenolic Acid (1)

    44 Nilotinib (1)

    45 Oritavancin Diphosphate (1)

    46 Orlistat (2)

    47 Papain (1)

    48 Pimecrolimus (1)

    49 Pioglitazone (1)

    50 Pioglitazone Hydrochloride (2)

    51 Pomalidomide (1)

    52 Posaconazole (2)

    53 Pravastatin (2)

    54 Repaglinide (1)

    55 Rivaroxaban (1)

    56 Rosiglitazone Maleate (1)

    57 Rosuvastatin Calcium (2)

    58 Sacubitril Sodium (1)

    59 Sacubitril-Valsartan (1)

    60 Sevelamer Carbonate (1)

    61 Silodosin (1)

    62 Simvastatin (4)

    63 Sirolimus (1)

    64 Sitagliptin Hydrochloride (1)

    65 Sitagliptin Phosphate (2)

    66 Tacrolimus (3)

    67 Temsirolimus (1)

    68 Teriflunomide (1)

    69 Travoprost (1)

    70 Valsartan (1)

    71 Vildagliptin (2)

    72 Blank (3)

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    01 Active (59)

    02 Inactive (12)

    03 Blank (32)

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    01 Valid (27)

    02 Withdrawn by Holder (4)

    03 Blank (72)

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    01 223MF10033 (1)

    02 223MF10038 (1)

    03 223MF10039 (1)

    04 225MF10102 (1)

    05 226MF10213 (1)

    06 229MF10178 (1)

    07 230MF10166 (1)

    08 231MF10044 (1)

    09 304MF10035 (1)

    10 Blank (94)

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    01 WC-0038 (8)

    02 WC-0038A2 (3)

    03 WC-0100 (12)

    04 WC-0100(3) (1)

    05 WC-0100-(1) (1)

    06 WC-0100-A5 (2)

    07 WC-0100A (1)

    08 WC-0100A7 (1)

    09 WC-0100A8 (1)

    10 WC-0109 (11)

    11 WC-0109A3 (2)

    12 WC-0405 (1)

    13 WC-0405A2 (1)

    14 WC-100(2) (1)

    15 Blank (57)

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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

    PDF Supplier PDF
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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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    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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    Atorvastatin

    PDF Supplier PDF
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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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    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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    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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