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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by HONOUR LAB LTD

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    HONOUR LAB LTD
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    Country
    Country
    India
    Address
    Address
    H.no: 8-3-166/7/1, Erragadda, Hyderabad-18
    Telephone
    Telephone
    +91 9392471695
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    Email
    enquiries@pharmacompass.com
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    http://honourlab.com/
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    • FDA
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    30857
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    2016-09-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2016-324 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2019-08-12
    Japanese DMF

    Found JDMF

    303MF10124
    Sitagliptin Phosphate at H. No. &8-...
    2021-08-16
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Sitagliptin Phosphate IH
    2019-07-26
    Application Number
    30857
    R0-CEP 2016-324 - Rev 00
    303MF10124
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-05-05
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    Sitagliptin phosphate monohydrate
    Sitagliptin Phosphate at H. No. &8-...
    Sitagliptin Phosphate IH
    Issue/Submission Date
    2016-09-22
    2019-08-12
    2021-08-16
    2019-07-26
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    • FDA
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    Tadalafil

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    USDMF

    Found USDMF

    29765
    Active
    TADALAFIL USP
    2015-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-083 - Rev 00
    Valid
    Tadalafil
    2022-07-25
    Japanese DMF

    Found JDMF

    230MF10172
    Tadalafil [D] at H. No. &8-3-166/7/...
    2018-12-21
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Tadalafil BP/USP/EP
    2019-07-26
    Application Number
    29765
    R1-CEP 2016-083 - Rev 00
    230MF10172
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-05-05
    Filing Details
    TADALAFIL USP
    Tadalafil
    Tadalafil [D] at H. No. &8-3-166/7/...
    Tadalafil BP/USP/EP
    Issue/Submission Date
    2015-12-04
    2022-07-25
    2018-12-21
    2019-07-26
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    • FDA
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    Alogliptin Benzoate

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    USDMF

    Found USDMF

    30577
    Active
    ALOGLIPTIN BENZOATE
    2016-07-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    306MF10015
    Alogliptin benzoate “D” at H. N...
    2024-01-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Alogliptin Benzoate IH
    2019-07-26
    Application Number
    30577
    306MF10015
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    ALOGLIPTIN BENZOATE
    Alogliptin benzoate “D” at H. N...
    Alogliptin Benzoate IH
    Issue/Submission Date
    2016-07-18
    2024-01-24
    2019-07-26
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    • FDA
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    Clobazam

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    USDMF

    Found USDMF

    29351
    Active
    CLOBAZAM
    2015-06-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-237 - Rev 00
    Valid
    Clobazam
    2023-02-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Clobazam
    2019-07-26
    Application Number
    29351
    R1-CEP 2016-237 - Rev 00
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-05-05
    Filing Details
    CLOBAZAM
    Clobazam
    Clobazam
    Issue/Submission Date
    2015-06-02
    2023-02-13
    2019-07-26
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    • FDA
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28225
    Active
    FINGOLIMOD HYDROCHLORIDE
    2014-04-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-171 - Rev 01
    Valid
    Fingolimod hydrochloride
    2023-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Fingolimod Hydrochloride (IH)
    2019-07-26
    Application Number
    28225
    R0-CEP 2019-171 - Rev 01
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-05-05
    Filing Details
    FINGOLIMOD HYDROCHLORIDE
    Fingolimod hydrochloride
    Fingolimod Hydrochloride (IH)
    Issue/Submission Date
    2014-04-22
    2023-07-27
    2019-07-26
    ASK
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    • FDA
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    Linagliptin

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    USDMF

    Found USDMF

    28877
    Active
    LINAGLIPTIN
    2015-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10029
    linagliptin hydrate at H. No. &8-3-...
    2023-02-15
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Linagliptin (IH)
    2019-07-26
    Application Number
    28877
    305MF10029
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    LINAGLIPTIN
    linagliptin hydrate at H. No. &8-3-...
    Linagliptin (IH)
    Issue/Submission Date
    2015-01-07
    2023-02-15
    2019-07-26
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    Vildagliptin

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    USDMF

    Found USDMF

    36545
    Active
    VILDAGLIPTIN
    2022-01-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10116
    Vildagliptin [D] at H. No. &8-3-166...
    2018-08-22
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Vildagliptin IH
    2019-07-26
    Application Number
    36545
    230MF10116
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-05-05
    Filing Details
    VILDAGLIPTIN
    Vildagliptin [D] at H. No. &8-3-166...
    Vildagliptin IH
    Issue/Submission Date
    2022-01-03
    2018-08-22
    2019-07-26
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    • FDA
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    Pirfenidone

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    See Less

    USDMF

    Found USDMF

    29700
    Active
    PIRFENIDONE
    2015-11-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-122 - Rev 00
    Valid
    Pirfenidone
    2022-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29700
    R1-CEP 2016-122 - Rev 00
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Issue/Submission Date
    2015-11-04
    2022-10-19
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    • FDA
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    Apixaban

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    USDMF

    Found USDMF

    30461
    Active
    APIXABAN
    2016-05-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Apixaban IH
    2019-07-26
    Application Number
    30461
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2016-05-18
    2019-07-26
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    • FDA
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    Azilsartan

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    See Less

    USDMF

    Found USDMF

    31895
    Active
    AZILSARTAN KAMEDOXOMIL
    2017-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Azilsartan Kamedoxomil
    2019-07-26
    Application Number
    31895
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    AZILSARTAN KAMEDOXOMIL
    Azilsartan Kamedoxomil
    Issue/Submission Date
    2017-11-28
    2019-07-26
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    • FDA
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    Bosentan Hydrate

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    See Less

    USDMF

    Found USDMF

    36018
    Active
    BOSENTAN MONOHYDRATE
    2021-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Bosetan Monohydrate(IH)
    2019-07-26
    Application Number
    36018
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-05-05
    Filing Details
    BOSENTAN MONOHYDRATE
    Bosetan Monohydrate(IH)
    Issue/Submission Date
    2021-09-09
    2019-07-26
    ASK
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    • FDA
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    Brexpiprazole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    32532
    Active
    BREXPIPRAZOLE
    2018-06-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Brexpiprazole IH
    2019-05-06
    Application Number
    32532
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    BREXPIPRAZOLE
    Brexpiprazole IH
    Issue/Submission Date
    2018-06-04
    2019-05-06
    ASK
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    • FDA
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    Colchicine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29401
    Active
    COLCHICINE (FORM-A)
    2015-06-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Colchicine
    2019-07-26
    Application Number
    29401
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    COLCHICINE (FORM-A)
    Colchicine
    Issue/Submission Date
    2015-06-05
    2019-07-26
    ASK
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    • FDA
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    Dimethyl Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29485
    Active
    DIMETHYL FUMARATE
    2015-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Dimethyl Fumarate
    2019-07-26
    Application Number
    29485
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate
    Issue/Submission Date
    2015-07-23
    2019-07-26
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    • FDA
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    Edoxaban Tosylate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    32401
    Active
    EDOXABAN TOSYLATE MONOHYDRATE
    2018-02-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Edoxaban Tosylate Monohydrate IH
    2019-05-06
    Application Number
    32401
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    EDOXABAN TOSYLATE MONOHYDRATE
    Edoxaban Tosylate Monohydrate IH
    Issue/Submission Date
    2018-02-06
    2019-05-06
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    • FDA
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    Macitentan

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    31213
    Active
    MACITENTAN
    2017-01-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Macitentan IH
    2019-05-06
    Application Number
    31213
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    MACITENTAN
    Macitentan IH
    Issue/Submission Date
    2017-01-05
    2019-05-06
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    Nebivolol

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    USDMF

    Found USDMF

    28627
    Active
    NEBIVOLOL HYDROCHLORIDE
    2014-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Nebivolol Hydrochloride(IH)
    2019-07-26
    Application Number
    28627
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    NEBIVOLOL HYDROCHLORIDE
    Nebivolol Hydrochloride(IH)
    Issue/Submission Date
    2014-09-10
    2019-07-26
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    • FDA
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    Posaconazole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    32973
    Active
    POSACONAZOLE (FORM-I)
    2018-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Posaconazole IH
    2019-05-06
    Application Number
    32973
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    POSACONAZOLE (FORM-I)
    Posaconazole IH
    Issue/Submission Date
    2018-08-28
    2019-05-06
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    • FDA
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    Sacubitril-Valsartan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33657
    Active
    SACUBITRIL VALSARTAN SODIUM ON COLL...
    2019-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Sacubitril And Valsartan IH
    2019-05-06
    Application Number
    33657
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    SACUBITRIL VALSARTAN SODIUM ON COLL...
    Sacubitril And Valsartan IH
    Issue/Submission Date
    2019-05-09
    2019-05-06
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    Tavaborole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    32533
    Active
    TAVABOROLE
    2018-04-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-362
    Expired
    Tavaborole IH
    2019-05-06
    Application Number
    32533
    Indian CDSCO WC-362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    TAVABOROLE
    Tavaborole IH
    Issue/Submission Date
    2018-04-27
    2019-05-06
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    Ticagrelor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28879
    Active
    TICAGRELOR
    2015-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0362
    Expired
    Ticagrelor (IH)
    2019-07-26
    Application Number
    28879
    Indian CDSCO WC-0362
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Expired
    2022-05-05
    Filing Details
    TICAGRELOR
    Ticagrelor (IH)
    Issue/Submission Date
    2015-01-07
    2019-07-26
    ASK
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    Avanafil

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    30024
    Active
    AVANAFIL
    2015-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30024
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    AVANAFIL
    Issue/Submission Date
    2015-12-15
    ASK
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    Brivaracetam

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    34569
    Active
    BRIVARACETAM
    2020-02-18
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34569
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    BRIVARACETAM
    Issue/Submission Date
    2020-02-18
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    Chlorthalidone

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    USDMF

    Found USDMF

    35236
    Active
    CHLORTHALIDONE
    2021-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    35236
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    CHLORTHALIDONE
    Issue/Submission Date
    2021-08-31
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    Clorazepate Dipotassium

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    USDMF

    Found USDMF

    37475
    Active
    CLORAZEPATE DIPOTASSIUM
    2022-09-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    37475
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    CLORAZEPATE DIPOTASSIUM
    Issue/Submission Date
    2022-09-20
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    Cobicistat

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    USDMF

    Found USDMF

    30287
    Active
    COBICISTAT ON COLLOIDAL SILICON DI...
    2016-09-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30287
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    COBICISTAT ON COLLOIDAL SILICON DI...
    Issue/Submission Date
    2016-09-07
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    Crisaborole

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    USDMF

    Found USDMF

    33060
    Active
    CRISABOROLE
    2019-01-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33060
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    CRISABOROLE
    Issue/Submission Date
    2019-01-11
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    Dapagliflozin

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    USDMF

    Found USDMF

    31235
    Active
    DAPAGLIFLOZIN (AMORPHOUS)
    2017-03-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31235
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN (AMORPHOUS)
    Issue/Submission Date
    2017-03-23
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    Dapagliflozin Propanediol Monohydrate

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    USDMF

    Found USDMF

    32972
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2018-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32972
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Issue/Submission Date
    2018-11-03
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    Diatrizoate Meglumine

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    USDMF

    Found USDMF

    34403
    Active
    DIATRIZOATE MEGLUMINE
    2020-04-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34403
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DIATRIZOATE MEGLUMINE
    Issue/Submission Date
    2020-04-09
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    Diatrizoate Sodium

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    USDMF

    Found USDMF

    34430
    Active
    DIATRIZOATE SODIUM
    2020-03-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34430
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DIATRIZOATE SODIUM
    Issue/Submission Date
    2020-03-06
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    Dicyclomine Hydrochloride

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    USDMF

    Found USDMF

    36977
    Active
    DICYCLOMINE HYDROCHLORIDE
    2022-04-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36977
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DICYCLOMINE HYDROCHLORIDE
    Issue/Submission Date
    2022-04-04
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    Diroximel fumarate

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    USDMF

    Found USDMF

    36019
    Active
    DIROXIMEL FUMARATE
    2021-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36019
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DIROXIMEL FUMARATE
    Issue/Submission Date
    2021-09-20
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    Doxylamine Succinate

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    USDMF

    Found USDMF

    37476
    Active
    DOXYLAMINE SUCCINATE
    2022-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37476
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DOXYLAMINE SUCCINATE
    Issue/Submission Date
    2022-12-17
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    Eluxadoline

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    USDMF

    Found USDMF

    33384
    Active
    ELUXADOLINE
    2018-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33384
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    ELUXADOLINE
    Issue/Submission Date
    2018-12-19
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    Empagliflozin

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    USDMF

    Found USDMF

    31523
    Active
    EMPAGLIFLOZIN
    2017-06-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31523
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2017-06-02
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    Empagliflozin

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    USDMF

    Found USDMF

    32534
    Active
    EMPAGLIFLOZIN (AMORPHOUS)
    2018-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32534
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    EMPAGLIFLOZIN (AMORPHOUS)
    Issue/Submission Date
    2018-04-02
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    Ertugliflozin

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    USDMF

    Found USDMF

    36283
    Active
    ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
    2021-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36283
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
    Issue/Submission Date
    2021-09-30
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    Linagliptin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28878
    Active
    LINAGLIPTIN PREMIX
    2015-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28878
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    LINAGLIPTIN PREMIX
    Issue/Submission Date
    2015-01-07
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    Molnupiravir

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    USDMF

    Found USDMF

    36282
    Active
    MOLNUPIRAVIR
    2021-10-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36282
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MOLNUPIRAVIR
    Issue/Submission Date
    2021-10-13
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    Monomethyl Fumarate

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    USDMF

    Found USDMF

    30153
    Active
    MONOMETHYL FUMARATE
    2016-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30153
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    MONOMETHYL FUMARATE
    Issue/Submission Date
    2016-01-18
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    Nirmatrelvir

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    USDMF

    Found USDMF

    36910
    Active
    NIRMATRELVIR
    2022-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36910
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    NIRMATRELVIR
    Issue/Submission Date
    2022-03-25
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    Ospemifene

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    USDMF

    Found USDMF

    30858
    Active
    OSPEMIFENE
    2016-10-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30858
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    OSPEMIFENE
    Issue/Submission Date
    2016-10-17
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    Remdesivir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35970
    Active
    REMDESIVIR
    2021-06-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35970
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    REMDESIVIR
    Issue/Submission Date
    2021-06-11
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    Sapropterin Hydrochloride

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    USDMF

    Found USDMF

    33928
    Active
    SAPROPTERIN DIHYDROCHLORIDE
    2019-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33928
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SAPROPTERIN DIHYDROCHLORIDE
    Issue/Submission Date
    2019-08-06
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    Selexipag

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    USDMF

    Found USDMF

    33061
    Active
    SELEXIPAG (AMORPHOUS)
    2018-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33061
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SELEXIPAG (AMORPHOUS)
    Issue/Submission Date
    2018-12-31
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    32968
    Active
    SITAGLIPTIN PHOSPHATE ANHYDROUS
    2018-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32968
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SITAGLIPTIN PHOSPHATE ANHYDROUS
    Issue/Submission Date
    2018-08-01
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    Sugammadex Sodium

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    USDMF

    Found USDMF

    34113
    Active
    SUGAMMADEX SODIUM
    2019-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34113
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM
    Issue/Submission Date
    2019-10-01
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    Teriflunomide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29701
    Active
    TERIFLUNOMIDE
    2015-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29701
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    TERIFLUNOMIDE
    Issue/Submission Date
    2015-10-01
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    Tofacitinib Citrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36542
    Active
    TOFACITINIB CITRATE
    2022-06-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36542
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    TOFACITINIB CITRATE
    Issue/Submission Date
    2022-06-03
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