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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Jubilant Life Sciences Limited

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    Jubilant Generics
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    Country
    Country
    India
    Address
    Address
    Bhartiagram Gajraula, Distt. Amroha - 244223, Uttar Pradesh, India
    Telephone
    Telephone
    +91 120 4361000
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.jubilantgenerics.com/
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    Donepezil

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    USDMF

    Found USDMF

    19048
    Active
    DONEPEZIL HYDROCHLORIDE USP (ANHYDR...
    2005-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10189
    Donepezil hydrochloride at 1A, Sect...
    2010-07-06
    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Donepezil Hydrochloride IH
    2021-12-02
    Application Number
    19048
    222MF10189
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2024-11-04
    Filing Details
    DONEPEZIL HYDROCHLORIDE USP (ANHYDR...
    Donepezil hydrochloride at 1A, Sect...
    Donepezil Hydrochloride IH
    Issue/Submission Date
    2005-12-16
    2010-07-06
    2021-12-02
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    Galantamine Hydrobromide

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    USDMF

    Found USDMF

    21989
    Active
    GALANTAMINE HYDROBROMIDE
    2008-11-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-123 - Rev 02
    Valid
    Galantamine hydrobromide, Produced ...
    2022-08-12
    Japanese DMF

    Found JDMF

    231MF10054
    Galantamine Hydrobromide at 1A, Sec...
    2019-02-21
    Written Confirmation

    Close WC

    Application Number
    21989
    R1-CEP 2011-123 - Rev 02
    231MF10054
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GALANTAMINE HYDROBROMIDE
    Galantamine hydrobromide, Produced ...
    Galantamine Hydrobromide at 1A, Sec...
    Issue/Submission Date
    2008-11-26
    2022-08-12
    2019-02-21
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    Lacosamide

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    USDMF

    Found USDMF

    29170
    Active
    LACOSAMIDE
    2015-03-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-049 - Rev 01
    Valid
    Lacosamide
    2022-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Lacosamide IH
    2021-12-02
    Application Number
    29170
    R0-CEP 2019-049 - Rev 01
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2024-11-04
    Filing Details
    LACOSAMIDE
    Lacosamide
    Lacosamide IH
    Issue/Submission Date
    2015-03-28
    2022-08-12
    2021-12-02
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    Losartan Potassium

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    USDMF

    Found USDMF

    21177
    Active
    LOSARTAN POTASSIUM USP
    2007-12-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-374 - Rev 04
    Valid
    Losartan potassium
    2022-11-03
    Japanese DMF

    Found JDMF

    223MF10010
    Japanese Pharmacopoeia losartan pot...
    2011-01-21
    Written Confirmation

    Close WC

    Application Number
    21177
    R1-CEP 2009-374 - Rev 04
    223MF10010
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LOSARTAN POTASSIUM USP
    Losartan potassium
    Japanese Pharmacopoeia losartan pot...
    Issue/Submission Date
    2007-12-10
    2022-11-03
    2011-01-21
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    Olanzapine

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    USDMF

    Found USDMF

    20990
    Active
    OLANZAPINE USP (FORM-I)
    2007-10-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-030 - Rev 01
    Valid
    Olanzapine
    2022-10-11
    Japanese DMF

    Found JDMF

    227MF10037
    Olanzapine at 1A, Sector 16A, Noida...
    2015-02-04
    Written Confirmation

    Close WC

    Application Number
    20990
    R1-CEP 2011-030 - Rev 01
    227MF10037
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OLANZAPINE USP (FORM-I)
    Olanzapine
    Olanzapine at 1A, Sector 16A, Noida...
    Issue/Submission Date
    2007-10-22
    2022-10-11
    2015-02-04
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    26929
    Active
    OLMESARTAN MEDOXOMIL USP
    2013-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-325 - Rev 01
    Valid
    Olmesartan medoxomil
    2022-08-12
    Japanese DMF

    Found JDMF

    227MF10303
    Japanese Pharmacopoeia olmesartan m...
    2015-12-28
    Written Confirmation

    Close WC

    Application Number
    26929
    R1-CEP 2013-325 - Rev 01
    227MF10303
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan medoxomil
    Japanese Pharmacopoeia olmesartan m...
    Issue/Submission Date
    2013-03-29
    2022-08-12
    2015-12-28
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    Paroxetine Hydrochloride

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    USDMF

    Found USDMF

    22337
    Active
    PAROXETINE HYDROCHLORIDE-USP (HEMIH...
    2009-03-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-204 - Rev 02
    Valid
    Paroxetine hydrochloride hemihydrat...
    2022-08-23
    Japanese DMF

    Found JDMF

    231MF10081
    Japanese Pharmacopoeia Paroxetine H...
    2019-04-03
    Written Confirmation

    Close WC

    Application Number
    22337
    R1-CEP 2009-204 - Rev 02
    231MF10081
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PAROXETINE HYDROCHLORIDE-USP (HEMIH...
    Paroxetine hydrochloride hemihydrat...
    Japanese Pharmacopoeia Paroxetine H...
    Issue/Submission Date
    2009-03-26
    2022-08-23
    2019-04-03
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    Risedronate Sodium

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    USDMF

    Found USDMF

    19968
    Active
    RISEDRONATE SODIUM HEMIPENTAHYDRATE...
    2006-11-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-010 - Rev 01
    Valid
    Risedronate sodium 2.5-hydrate
    2022-08-23
    Japanese DMF

    Found JDMF

    222MF10033
    Sodium risedronate hydrate at 1A, S...
    2010-01-26
    Written Confirmation

    Close WC

    Application Number
    19968
    R1-CEP 2014-010 - Rev 01
    222MF10033
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RISEDRONATE SODIUM HEMIPENTAHYDRATE...
    Risedronate sodium 2.5-hydrate
    Sodium risedronate hydrate at 1A, S...
    Issue/Submission Date
    2006-11-03
    2022-08-23
    2010-01-26
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    Risperidone

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    USDMF

    Found USDMF

    16517
    Active
    RISPERIDONE-USP
    2003-04-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-151 - Rev 07
    Valid
    Risperidone
    2022-08-23
    Japanese DMF

    Found JDMF

    229MF10019
    Japanese Pharmacopoeia risperidone ...
    2017-01-25
    Written Confirmation

    Close WC

    Application Number
    16517
    R1-CEP 2002-151 - Rev 07
    229MF10019
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RISPERIDONE-USP
    Risperidone
    Japanese Pharmacopoeia risperidone ...
    Issue/Submission Date
    2003-04-08
    2022-08-23
    2017-01-25
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    30082
    Active
    SITAGLIPTIN PHOSPHATE USP
    2015-12-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-175 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2023-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Sitagliptin phosphate monohydrate I...
    2021-12-02
    Application Number
    30082
    R0-CEP 2021-175 - Rev 00
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2024-11-04
    Filing Details
    SITAGLIPTIN PHOSPHATE USP
    Sitagliptin phosphate monohydrate
    Sitagliptin phosphate monohydrate I...
    Issue/Submission Date
    2015-12-22
    2023-08-31
    2021-12-02
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    Telmisartan

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    USDMF

    Found USDMF

    24052
    Active
    TELMISARTAN
    2010-11-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-209 - Rev 01
    Valid
    Telmisartan
    2022-08-31
    Japanese DMF

    Found JDMF

    227MF10304
    Japanese Pharmacopoeia telmisartan ...
    2015-12-28
    Written Confirmation

    Close WC

    Application Number
    24052
    R1-CEP 2011-209 - Rev 01
    227MF10304
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TELMISARTAN
    Telmisartan
    Japanese Pharmacopoeia telmisartan ...
    Issue/Submission Date
    2010-11-04
    2022-08-31
    2015-12-28
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    18803
    Active
    TRAMADOL HYDROCHLORIDE USP
    2005-09-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-199 - Rev 07
    Valid
    Tramadol hydrochloride
    2022-08-11
    Japanese DMF

    Found JDMF

    229MF10160
    Tramadol hydrochloride at 1A, Secto...
    2017-08-17
    Written Confirmation

    Close WC

    Application Number
    18803
    R1-CEP 2002-199 - Rev 07
    229MF10160
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRAMADOL HYDROCHLORIDE USP
    Tramadol hydrochloride
    Tramadol hydrochloride at 1A, Secto...
    Issue/Submission Date
    2005-09-27
    2022-08-11
    2017-08-17
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    Valsartan

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    USDMF

    Found USDMF

    18967
    Active
    VALSARTAN USP
    2005-11-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-110 - Rev 08
    Valid
    Valsartan
    2023-07-12
    Japanese DMF

    Found JDMF

    226MF10178
    Japanese Pharmacopoeia valsartan at...
    2014-09-01
    Written Confirmation

    Close WC

    Application Number
    18967
    R1-CEP 2011-110 - Rev 08
    226MF10178
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VALSARTAN USP
    Valsartan
    Japanese Pharmacopoeia valsartan at...
    Issue/Submission Date
    2005-11-22
    2023-07-12
    2014-09-01
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    Esomeprazole Magnesium

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    USDMF

    Caution USDMF

    21375
    Inactive
    ESOMEPRAZOLE MAGNESIUM
    2008-05-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-175 - Rev 01
    Valid
    Esomeprazole magnesium trihydrate, ...
    2023-08-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Esomeprazole Magnesium DihydrateIH
    2021-12-02
    Application Number
    21375
    R0-CEP 2023-175 - Rev 01
    Indian CDSCO WC-0092A
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2024-11-04
    Filing Details
    ESOMEPRAZOLE MAGNESIUM
    Esomeprazole magnesium trihydrate, ...
    Esomeprazole Magnesium DihydrateIH
    Issue/Submission Date
    2008-05-23
    2023-08-23
    2021-12-02
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    Alendronate Sodium

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    USDMF

    Found USDMF

    22333
    Active
    ALENDRONATE SODIUM USP
    2009-03-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-111 - Rev 01
    Valid
    Sodium alendronate trihydrate
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22333
    R1-CEP 2011-111 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ALENDRONATE SODIUM USP
    Sodium alendronate trihydrate
    Issue/Submission Date
    2009-03-31
    2022-08-24
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    Aliskiren

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    USDMF

    Found USDMF

    28050
    Active
    ALISKIREN HEMIFUMARATE
    2014-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    ALISKIREN HEMIFUMARATE IH
    2021-12-02
    Application Number
    28050
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2024-11-04
    Filing Details
    ALISKIREN HEMIFUMARATE
    ALISKIREN HEMIFUMARATE IH
    Issue/Submission Date
    2014-03-31
    2021-12-02
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    Aprepitant

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    USDMF

    Found USDMF

    26852
    Active
    APREPITANT USP
    2013-03-15
    CEP/COS

    Found CEP/COS

    CEP 2017-051 - Rev 01
    Valid
    Aprepitant
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26852
    CEP 2017-051 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    APREPITANT USP
    Aprepitant
    Issue/Submission Date
    2013-03-15
    2023-12-06
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    Aripiprazole

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    USDMF

    Found USDMF

    19739
    Active
    ARIPIPRAZOLE USP
    2006-08-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-324 - Rev 01
    Valid
    Aripiprazole
    2022-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19739
    R1-CEP 2013-324 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole
    Issue/Submission Date
    2006-08-31
    2022-08-11
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    Atorvastatin

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    USDMF

    Found USDMF

    21376
    Active
    ATORVASTATIN CALCIUM (AMORPHOUS)
    2008-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10204
    Atorvastatin calcium hydrate at 1A,...
    2010-07-21
    Written Confirmation

    Close WC

    Application Number
    21376
    222MF10204
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ATORVASTATIN CALCIUM (AMORPHOUS)
    Atorvastatin calcium hydrate at 1A,...
    Issue/Submission Date
    2008-08-01
    2010-07-21
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    Azithromycin

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    USDMF

    Found USDMF

    18868
    Active
    AZITHROMYCIN MONOHYDRATE USP
    2005-10-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-118 - Rev 05
    Valid
    Azithromycin, Monohydrate
    2022-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18868
    R1-CEP 2007-118 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZITHROMYCIN MONOHYDRATE USP
    Azithromycin, Monohydrate
    Issue/Submission Date
    2005-10-14
    2022-08-12
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    Azithromycin Dihydrate

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    USDMF

    Found USDMF

    30966
    Active
    AZITHROMYCIN DIHYDRATE USP
    2016-12-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-119 - Rev 06
    Valid
    Azithromycin, Dihydrate
    2022-09-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30966
    R1-CEP 2007-119 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZITHROMYCIN DIHYDRATE USP
    Azithromycin, Dihydrate
    Issue/Submission Date
    2016-12-01
    2022-09-29
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    Bosentan Hydrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28598
    Active
    BOSENTAN MONOHYDRATE
    2014-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Bosentan Monohydrate IH
    2021-12-02
    Application Number
    28598
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2024-11-04
    Filing Details
    BOSENTAN MONOHYDRATE
    Bosentan Monohydrate IH
    Issue/Submission Date
    2014-09-09
    2021-12-02
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    Carbamazepine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14410
    Active
    CARBAMAZEPINE USP
    1999-09-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-109 - Rev 06
    Valid
    Carbamazepine
    2022-08-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14410
    R1-CEP 1999-109 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARBAMAZEPINE USP
    Carbamazepine
    Issue/Submission Date
    1999-09-21
    2022-08-23
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    Cetirizine Dihydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20152
    Active
    CETIRIZINE DIHYDROCHLORIDE USP
    2007-01-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-114 - Rev 05
    Valid
    Cetirizine dihydrochloride
    2022-08-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20152
    R1-CEP 2007-114 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CETIRIZINE DIHYDROCHLORIDE USP
    Cetirizine dihydrochloride
    Issue/Submission Date
    2007-01-05
    2022-08-23
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    • FDA
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    Citalopram Hydrobromide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15587
    Active
    CITALOPRAM HYDROBROMIDE USP
    2001-08-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-379 - Rev 02
    Valid
    Citalopram hydrobromide, DGR proces...
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15587
    R1-CEP 2010-379 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CITALOPRAM HYDROBROMIDE USP
    Citalopram hydrobromide, DGR proces...
    Issue/Submission Date
    2001-08-21
    2022-08-24
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    Citalopram Hydrobromide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20013
    Active
    CITALOPRAM HYDROBROMIDE (DGR) USP
    2006-11-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-175 - Rev 05
    Valid
    Citalopram hydrobromide
    2023-07-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20013
    R1-CEP 2009-175 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CITALOPRAM HYDROBROMIDE (DGR) USP
    Citalopram hydrobromide
    Issue/Submission Date
    2006-11-24
    2023-07-10
    ASK
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    Clopidogrel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24496
    Active
    CLOPIDOGREL BISULFATE USP
    2011-02-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-267 - Rev 01
    Valid
    Clopidogrel hydrogen sulfate
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24496
    R1-CEP 2011-267 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLOPIDOGREL BISULFATE USP
    Clopidogrel hydrogen sulfate
    Issue/Submission Date
    2011-02-21
    2022-08-24
    ASK
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    Duloxetine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25890
    Active
    DULOXETINE HYDROCHLORIDE
    2012-03-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-012 - Rev 01
    Valid
    Duloxetine hydrochloride
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25890
    R1-CEP 2014-012 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DULOXETINE HYDROCHLORIDE
    Duloxetine hydrochloride
    Issue/Submission Date
    2012-03-29
    2022-08-24
    ASK
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    Escitalopram Oxalate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19446
    Active
    ESCITALOPRAM OXALATE USP
    2006-05-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-082 - Rev 00
    Valid
    Escitalopram oxalate
    2023-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19446
    R1-CEP 2017-082 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESCITALOPRAM OXALATE USP
    Escitalopram oxalate
    Issue/Submission Date
    2006-05-12
    2023-06-09
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    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22335
    Active
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    2010-12-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-111 - Rev 02
    Valid
    Esomeprazole magnesium trihydrate
    2023-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22335
    R1-CEP 2014-111 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ESOMEPRAZOLE MAGNESIUM DIHYDRATE
    Esomeprazole magnesium trihydrate
    Issue/Submission Date
    2010-12-07
    2023-04-26
    ASK
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    your Marketing & Sales content
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    • FDA
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    Febuxostat

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30353
    Active
    FEBUXOSTAT
    2016-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Febuxostat IH
    2021-12-02
    Application Number
    30353
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2024-11-04
    Filing Details
    FEBUXOSTAT
    Febuxostat IH
    Issue/Submission Date
    2016-03-30
    2021-12-02
    ASK
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    your Marketing & Sales content
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    • FDA
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    Irbesartan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19790
    Active
    IRBESARTAN USP
    2006-09-14
    CEP/COS

    Found CEP/COS

    CEP 2011-087 - Rev 04
    Valid
    Irbesartan
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19790
    CEP 2011-087 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Issue/Submission Date
    2006-09-14
    2024-03-25
    ASK
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    • FDA
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    Lamotrigine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16142
    Active
    LAMOTRIGINE USP
    2002-09-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-162 - Rev 02
    Valid
    Lamotrigine
    2022-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16142
    R1-CEP 2009-162 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Issue/Submission Date
    2002-09-24
    2022-08-12
    ASK
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    • FDA
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    Lansoprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21988
    Active
    LANSOPRAZOLE USP
    2009-11-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-263 - Rev 01
    Valid
    Lansoprazole
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21988
    R1-CEP 2011-263 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LANSOPRAZOLE USP
    Lansoprazole
    Issue/Submission Date
    2009-11-10
    2022-08-24
    ASK
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    • FDA
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    Levetiracetam

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24200
    Active
    LEVETIRACETAM USP
    2010-10-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-159 - Rev 01
    Valid
    Levetiracetam
    2022-08-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24200
    R1-CEP 2011-159 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam
    Issue/Submission Date
    2010-10-28
    2022-08-23
    ASK
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    • FDA
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    Linezolid

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

    See Less

    USDMF

    Found USDMF

    26928
    Active
    LINEZOLID FORM 1
    2013-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10153
    Linezolid at 1A, Sector 16A, Noida ...
    2013-08-09
    Written Confirmation

    Close WC

    Application Number
    26928
    225MF10153
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LINEZOLID FORM 1
    Linezolid at 1A, Sector 16A, Noida ...
    Issue/Submission Date
    2013-03-28
    2013-08-09
    ASK
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    your Marketing & Sales content
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    • FDA
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    Meclizine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21987
    Active
    MECLIZINE HYDROCHLORIDE USP
    2008-12-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-078 - Rev 02
    Valid
    Meclozine dihydrochloride
    2022-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21987
    R1-CEP 2011-078 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MECLIZINE HYDROCHLORIDE USP
    Meclozine dihydrochloride
    Issue/Submission Date
    2008-12-05
    2022-08-12
    ASK
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    your Marketing & Sales content
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    • FDA
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    Oxcarbazepine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16430
    Active
    OXCARBAZEPINE USP
    2003-03-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-059 - Rev 01
    Valid
    Oxcarbazepine
    2022-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16430
    R1-CEP 2014-059 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXCARBAZEPINE USP
    Oxcarbazepine
    Issue/Submission Date
    2003-03-11
    2022-08-11
    ASK
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    • FDA
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    Pantoprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20989
    Active
    PANTOPRAZOLE SODIUM USP
    2007-10-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-272 - Rev 03
    Valid
    Pantoprazole sodium sesquihydrate
    2022-08-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20989
    R1-CEP 2009-272 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2007-10-23
    2022-08-23
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    your Marketing & Sales content
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    • FDA
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    Ranolazine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31160
    Active
    RANOLAZINE
    2016-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Ranolazine IH
    2021-12-02
    Application Number
    31160
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2024-11-04
    Filing Details
    RANOLAZINE
    Ranolazine IH
    Issue/Submission Date
    2016-11-30
    2021-12-02
    ASK
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    • FDA
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    Repaglinide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24519
    Active
    REPAGLINIDE USP
    2011-03-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-202 - Rev 01
    Valid
    Repaglinide
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24519
    R1-CEP 2011-202 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    REPAGLINIDE USP
    Repaglinide
    Issue/Submission Date
    2011-03-22
    2022-08-24
    ASK
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    • FDA
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    Rivaroxaban

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

    See Less

    USDMF

    Found USDMF

    31381
    Active
    RIVAROXABAN
    2017-03-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Rivaroxaban IH
    2021-12-02
    Application Number
    31381
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2024-11-04
    Filing Details
    RIVAROXABAN
    Rivaroxaban IH
    Issue/Submission Date
    2017-03-23
    2021-12-02
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rivastigmine Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24501
    Active
    RIVASTIGMINE TARTRATE
    2011-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Rivastigmine Tartrate IH
    2021-12-02
    Application Number
    24501
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2024-11-04
    Filing Details
    RIVASTIGMINE TARTRATE
    Rivastigmine Tartrate IH
    Issue/Submission Date
    2011-03-27
    2021-12-02
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rizatriptan Benzoate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24054
    Active
    RIZATRIPTAN BENZOATE USP
    2010-11-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-273 - Rev 02
    Valid
    Rizatriptan benzoate
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24054
    R1-CEP 2012-273 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RIZATRIPTAN BENZOATE USP
    Rizatriptan benzoate
    Issue/Submission Date
    2010-11-04
    2022-08-24
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rosuvastatin Calcium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27813
    Active
    ROSUVASTATIN CALCIUM AMORPHOUS
    2014-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0092A
    Valid
    Rosuvastatin Calcium IH
    2021-12-02
    Application Number
    27813
    Indian CDSCO WC-0092A
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2024-11-04
    Filing Details
    ROSUVASTATIN CALCIUM AMORPHOUS
    Rosuvastatin Calcium IH
    Issue/Submission Date
    2014-03-14
    2021-12-02
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    Solifenacin Succinate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24765
    Active
    SOLIFENACIN SUCCINATE
    2011-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-080 - Rev 01
    Valid
    Solifenacin succinate
    2022-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24765
    R1-CEP 2016-080 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin succinate
    Issue/Submission Date
    2011-03-28
    2022-08-11
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    Tadalafil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27246
    Active
    TADALAFIL-USP
    2013-06-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-276 - Rev 01
    Valid
    Tadalafil
    2022-08-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27246
    R1-CEP 2013-276 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TADALAFIL-USP
    Tadalafil
    Issue/Submission Date
    2013-06-28
    2022-08-12
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    Voriconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27256
    Active
    VORICONAZOLE USP
    2013-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-286 - Rev 01
    Valid
    Voriconazole
    2022-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27256
    R1-CEP 2013-286 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VORICONAZOLE USP
    Voriconazole
    Issue/Submission Date
    2013-09-20
    2022-08-24
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    Zoledronic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20052
    Active
    ZOLEDRONIC ACID
    2006-12-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-349 - Rev 01
    Valid
    Zoledronic acid monohydrate
    2022-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20052
    R0-CEP 2019-349 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ZOLEDRONIC ACID
    Zoledronic acid monohydrate
    Issue/Submission Date
    2006-12-16
    2022-08-11
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    Zolmitriptan

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    USDMF

    Found USDMF

    23627
    Active
    ZOLMITRIPTAN USP
    2010-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10053
    Zolmitriptan at 1A, Sector 16A, Noi...
    2014-03-06
    Written Confirmation

    Close WC

    Application Number
    23627
    226MF10053
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZOLMITRIPTAN USP
    Zolmitriptan at 1A, Sector 16A, Noi...
    Issue/Submission Date
    2010-03-29
    2014-03-06
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