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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Cadila Pharmaceuticals

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    Cadila Pharmaceuticals
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    Country
    Country
    India
    Address
    Address
    Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210
    Telephone
    Telephone
    +91 2718 225001
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.cadilapharma.com/
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    • FDA
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    16911
    Active
    AMLODIPINE BESYLATE USP
    2003-09-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-293 - Rev 02
    Valid
    Amlodipine besilate
    2021-02-26
    Japanese DMF

    Found JDMF

    228MF10033
    Amlodipine besylate at Sarkhej-Dhol...
    2016-02-02
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Amlodipine Besilate (Ph. Eur./BP/US...
    2022-09-01
    Application Number
    16911
    R1-CEP 2007-293 - Rev 02
    228MF10033
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    AMLODIPINE BESYLATE USP
    Amlodipine besilate
    Amlodipine besylate at Sarkhej-Dhol...
    Amlodipine Besilate (Ph. Eur./BP/US...
    Issue/Submission Date
    2003-09-13
    2021-02-26
    2016-02-02
    2022-09-01
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    • FDA
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    Loratadine

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    USDMF

    Caution USDMF

    16025
    Inactive
    LORATIDINE
    2002-05-28
    CEP/COS

    Found CEP/COS

    CEP 2007-284 - Rev 03
    Valid
    Loratadine
    2024-01-04
    Japanese DMF

    Found JDMF

    222MF10187
    Loratadine (production only) at Sar...
    2010-07-02
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Loratadine (BP/USP/Ph. Eur.)
    2022-09-01
    Application Number
    16025
    CEP 2007-284 - Rev 03
    222MF10187
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LORATIDINE
    Loratadine
    Loratadine (production only) at Sar...
    Loratadine (BP/USP/Ph. Eur.)
    Issue/Submission Date
    2002-05-28
    2024-01-04
    2010-07-02
    2022-09-01
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    • FDA
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    Alendronate Sodium

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    USDMF

    Found USDMF

    20704
    Active
    ALEDRONATE SODIUM USP
    2007-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-230 - Rev 04
    Valid
    Sodium alendronate trihydrate
    2022-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Alendronate Sodium (USP)/EP
    2022-09-01
    Application Number
    20704
    R1-CEP 2008-230 - Rev 04
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ALEDRONATE SODIUM USP
    Sodium alendronate trihydrate
    Alendronate Sodium (USP)/EP
    Issue/Submission Date
    2007-07-11
    2022-09-14
    2022-09-01
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    • FDA
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    Bosentan Hydrate

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    USDMF

    Found USDMF

    26632
    Active
    BOSENTAN MONOHYDRATE
    2013-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10204
    Bosentan hydrate (production only) ...
    2015-08-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Bosentan Monohydrate IH
    2022-09-01
    Application Number
    26632
    227MF10204
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    BOSENTAN MONOHYDRATE
    Bosentan hydrate (production only) ...
    Bosentan Monohydrate IH
    Issue/Submission Date
    2013-03-05
    2015-08-10
    2022-09-01
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    • FDA
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    Celecoxib

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    USDMF

    Found USDMF

    19155
    Active
    CELECOXIB USP
    2006-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-220 - Rev 00
    Valid
    Celecoxib
    2022-05-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Celecoxib (Ph. Eur./USP)
    2022-09-01
    Application Number
    19155
    R1-CEP 2015-220 - Rev 00
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib (Ph. Eur./USP)
    Issue/Submission Date
    2006-01-19
    2022-05-16
    2022-09-01
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    • FDA
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    Chlorhexidine Gluconate

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    USDMF

    Found USDMF

    19583
    Active
    CHLORHEXIDINE GLUCONATE
    2006-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10908
    Chlorhexidine gluconate Sanshioeki ...
    2006-11-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Chlorhexidine Gluconate (Ph. Eur./B...
    2022-09-01
    Application Number
    19583
    218MF10908
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    CHLORHEXIDINE GLUCONATE
    Chlorhexidine gluconate Sanshioeki ...
    Chlorhexidine Gluconate (Ph. Eur./B...
    Issue/Submission Date
    2006-06-26
    2006-11-10
    2022-09-01
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    Desloratadine

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    USDMF

    Found USDMF

    21133
    Active
    DESLORATADINE
    2007-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-173 - Rev 00
    Valid
    Desloratadine
    2020-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Desloratadine (IH)
    2022-09-01
    Application Number
    21133
    R1-CEP 2014-173 - Rev 00
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DESLORATADINE
    Desloratadine
    Desloratadine (IH)
    Issue/Submission Date
    2007-12-11
    2020-10-16
    2022-09-01
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    • FDA
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    Fluoxetine Hydrochloride

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    USDMF

    Found USDMF

    14253
    Active
    FLUOXETINE HYDROCHLORIDE USP
    1999-06-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-207 - Rev 06
    Valid
    Fluoxetine hydrochloride
    2022-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Flouxetine HCL (Ph. Eur./BP/USP)
    2022-09-01
    Application Number
    14253
    R1-CEP 2004-207 - Rev 06
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    FLUOXETINE HYDROCHLORIDE USP
    Fluoxetine hydrochloride
    Flouxetine HCL (Ph. Eur./BP/USP)
    Issue/Submission Date
    1999-06-29
    2022-03-07
    2022-09-01
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    • FDA
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    Nebivolol

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    USDMF

    Found USDMF

    21152
    Active
    NEBIVOLOL HYDROCHLORIDE
    2007-12-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-095 - Rev 00
    Valid
    Nebivolol hydrochloride
    2022-08-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Nebivolol HCL
    2022-09-01
    Application Number
    21152
    R0-CEP 2022-095 - Rev 00
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    NEBIVOLOL HYDROCHLORIDE
    Nebivolol hydrochloride
    Nebivolol HCL
    Issue/Submission Date
    2007-12-08
    2022-08-31
    2022-09-01
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    • FDA
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    16786
    Active
    ONDANSETRON HYDROCHLORIDE USP
    2003-09-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-209 - Rev 03
    Valid
    Ondansetron hydrochloride dihydrate
    2020-03-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Ondansetron HCL (BP/Ph. Eur./USP)
    2022-09-01
    Application Number
    16786
    R1-CEP 2004-209 - Rev 03
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ONDANSETRON HYDROCHLORIDE USP
    Ondansetron hydrochloride dihydrate
    Ondansetron HCL (BP/Ph. Eur./USP)
    Issue/Submission Date
    2003-09-04
    2020-03-04
    2022-09-01
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    • FDA
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    Sildenafil Citrate

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    USDMF

    Found USDMF

    21154
    Active
    SILDENAFIL CITRATE USP
    2007-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-291 - Rev 00
    Valid
    Sildenafil citrate
    2019-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Sildenafil Citrate (USP/ Ph. Eur.)
    2022-09-01
    Application Number
    21154
    R1-CEP 2013-291 - Rev 00
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    SILDENAFIL CITRATE USP
    Sildenafil citrate
    Sildenafil Citrate (USP/ Ph. Eur.)
    Issue/Submission Date
    2007-12-13
    2019-12-16
    2022-09-01
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    • FDA
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    Venlafaxine Hydrochloride

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    USDMF

    Found USDMF

    19386
    Active
    VENLAFAXINE HYDROCHLORIDE USP
    2005-09-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-334 - Rev 00
    Valid
    Venlafaxine hydrochloride, Alternat...
    2016-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Venlafaxine HCL (Ph. Eur./BP/USP)
    2022-09-01
    Application Number
    19386
    R1-CEP 2010-334 - Rev 00
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP
    Venlafaxine hydrochloride, Alternat...
    Venlafaxine HCL (Ph. Eur./BP/USP)
    Issue/Submission Date
    2005-09-16
    2016-04-20
    2022-09-01
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    • FDA
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    Aripiprazole

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    USDMF

    Caution USDMF

    20464
    Inactive
    ARIPIPRAZOLE
    2007-04-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2016-308 - Rev 01
    Valid
    Aripiprazole
    2021-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Aripriprazole (IH)
    2022-09-01
    Application Number
    20464
    R0-CEP 2016-308 - Rev 01
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ARIPIPRAZOLE
    Aripiprazole
    Aripriprazole (IH)
    Issue/Submission Date
    2007-04-12
    2021-11-18
    2022-09-01
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    • FDA
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    Carvedilol

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    18515
    Inactive
    CARVEDILOL
    2005-07-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-083 - Rev 01
    Valid
    Carvedilol
    2013-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Carvedilol (USP/ Ph.Eur.)
    2022-09-01
    Application Number
    18515
    R1-CEP 2006-083 - Rev 01
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CARVEDILOL
    Carvedilol
    Carvedilol (USP/ Ph.Eur.)
    Issue/Submission Date
    2005-07-03
    2013-11-20
    2022-09-01
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    • FDA
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    Glibenclamide

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    USDMF

    Caution USDMF

    7989
    Inactive
    GLYBURIDE BP'88 (GLIBENCLAMIDE)
    1989-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10082
    Glibenclamide at Sarkhej-Dholka Roa...
    2019-10-25
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Glibenclamide (Ph. Eur./BP/JP)/Glyb...
    2022-09-01
    Application Number
    7989
    301MF10082
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    GLYBURIDE BP'88 (GLIBENCLAMIDE)
    Glibenclamide at Sarkhej-Dholka Roa...
    Glibenclamide (Ph. Eur./BP/JP)/Glyb...
    Issue/Submission Date
    1989-03-29
    2019-10-25
    2022-09-01
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    • FDA
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    Meloxicam

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    USDMF

    Caution USDMF

    19216
    Inactive
    MELOXICAM
    2006-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10171
    Meloxicam (production only) at Sark...
    2014-09-01
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Meloxicam (Ph. Eur./BP/USP)
    2022-09-01
    Application Number
    19216
    226MF10171
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    MELOXICAM
    Meloxicam (production only) at Sark...
    Meloxicam (Ph. Eur./BP/USP)
    Issue/Submission Date
    2006-01-19
    2014-09-01
    2022-09-01
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    Rupatadine Fumarate

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    USDMF

    Caution USDMF

    26210
    Inactive
    RUPATADINE FUMARATE
    2012-09-27
    CEP/COS

    Found CEP/COS

    CEP 2018-161 - Rev 02
    Valid
    Rupatadine fumarate
    2024-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Rupatadin Fumarate EP
    2022-09-01
    Application Number
    26210
    CEP 2018-161 - Rev 02
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    RUPATADINE FUMARATE
    Rupatadine fumarate
    Rupatadin Fumarate EP
    Issue/Submission Date
    2012-09-27
    2024-01-25
    2022-09-01
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    Amlodipine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27726
    Active
    PHTHALOYL AMLODIPINE
    2014-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10109
    Phthaloyl amlodipine (production on...
    2014-05-26
    Written Confirmation

    Close WC

    Application Number
    27726
    226MF10109
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHTHALOYL AMLODIPINE
    Phthaloyl amlodipine (production on...
    Issue/Submission Date
    2014-01-31
    2014-05-26
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    Atomoxetin Hydrochloride

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    USDMF

    Found USDMF

    22862
    Active
    ATOMOXETINE HYDROCHLORIDE USP
    2009-08-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Atomoxetine Hydrochloride (Ph. Eur....
    2022-09-01
    Application Number
    22862
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    ATOMOXETINE HYDROCHLORIDE USP
    Atomoxetine Hydrochloride (Ph. Eur....
    Issue/Submission Date
    2009-08-11
    2022-09-01
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    Bupropion Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28574
    Active
    BUPROPION HYDROCHLORIDE USP
    2014-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Bupropion Hydrochloride USP
    2022-09-01
    Application Number
    28574
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    BUPROPION HYDROCHLORIDE USP
    Bupropion Hydrochloride USP
    Issue/Submission Date
    2014-12-31
    2022-09-01
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    • FDA
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    Chlorhexidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19253
    Active
    CHLORHEXIDINE BASE
    2006-01-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10217
    Chlorhexidine to chlorine (producti...
    2013-12-03
    Written Confirmation

    Close WC

    Application Number
    19253
    225MF10217
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE BASE
    Chlorhexidine to chlorine (producti...
    Issue/Submission Date
    2006-01-03
    2013-12-03
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    • FDA
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    Cilostazol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF11022
    Cilostazol (production only) at Sar...
    2006-12-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Cilostazol USP/JP
    2022-09-01
    Application Number
    218MF11022
    Indian CDSCO WC-0074
    Status
     
    Valid
    2025-07-02
    Filing Details
    Cilostazol (production only) at Sar...
    Cilostazol USP/JP
    Issue/Submission Date
    2006-12-28
    2022-09-01
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    Desvenlafaxine Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22472
    Active
    O-DESMETHYL VENLAFAXINE SUCCINATE
    2009-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Desvenlafaxine Succinate IH
    2022-09-01
    Application Number
    22472
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    O-DESMETHYL VENLAFAXINE SUCCINATE
    Desvenlafaxine Succinate IH
    Issue/Submission Date
    2009-01-22
    2022-09-01
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    Escitalopram Oxalate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22440
    Active
    ESCITALOPRAM OXALATE USP
    2009-01-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Estalopram Oxalate (IH)
    2022-09-01
    Application Number
    22440
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ESCITALOPRAM OXALATE USP
    Estalopram Oxalate (IH)
    Issue/Submission Date
    2009-01-06
    2022-09-01
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    Ethambutol Dihydrochloride

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    USDMF

    Found USDMF

    11171
    Active
    ETHAMBUTOL HYDROCHLORIDE USP
    1994-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Ethambutol HCL (Ph. Eur./BP/USP)
    2022-09-01
    Application Number
    11171
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ETHAMBUTOL HYDROCHLORIDE USP
    Ethambutol HCL (Ph. Eur./BP/USP)
    Issue/Submission Date
    1994-10-31
    2022-09-01
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    Gemfibrozil

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    34933
    Active
    GEIBROZIL USP
    2020-07-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Gemfibrozil (USP)
    2022-09-01
    Application Number
    34933
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    GEIBROZIL USP
    Gemfibrozil (USP)
    Issue/Submission Date
    2020-07-10
    2022-09-01
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    Glibenclamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17093
    Active
    GLYBURIDE USP
    2004-01-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10993
    Glibenclamide (production only) at ...
    2006-12-18
    Written Confirmation

    Close WC

    Application Number
    17093
    218MF10993
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLYBURIDE USP
    Glibenclamide (production only) at ...
    Issue/Submission Date
    2004-01-14
    2006-12-18
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    • FDA
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    Hydralazine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    34945
    Active
    HYDRALAZINE HYDROCHLORIDE USP
    2020-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Hydralazine Hydrochloride IH
    2022-09-01
    Application Number
    34945
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    HYDRALAZINE HYDROCHLORIDE USP
    Hydralazine Hydrochloride IH
    Issue/Submission Date
    2020-07-03
    2022-09-01
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    • FDA
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    Olanzapine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22301
    Active
    OLANZAPINE FORM-I USP
    2008-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Olanzapine (IH)
    2022-09-01
    Application Number
    22301
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    OLANZAPINE FORM-I USP
    Olanzapine (IH)
    Issue/Submission Date
    2008-12-09
    2022-09-01
    ASK
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    • FDA
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22861
    Active
    OLMESARTAN MEDOXOMIL USP
    2009-08-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Olmesartan Medoxomil (IH)
    2022-09-01
    Application Number
    22861
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    OLMESARTAN MEDOXOMIL USP
    Olmesartan Medoxomil (IH)
    Issue/Submission Date
    2009-08-26
    2022-09-01
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    • FDA
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    Paliperidone

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    23871
    Active
    PALIPERIDONE USP
    2010-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Paliperidone (IH)
    2022-09-01
    Application Number
    23871
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PALIPERIDONE USP
    Paliperidone (IH)
    Issue/Submission Date
    2010-11-29
    2022-09-01
    ASK
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    • FDA
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    Pranlukast Hydrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10125
    Pranlukast hydrate (production only...
    2011-07-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Pranlukast
    2022-09-01
    Application Number
    223MF10125
    Indian CDSCO WC-0074
    Status
     
    Valid
    2025-07-02
    Filing Details
    Pranlukast hydrate (production only...
    Pranlukast
    Issue/Submission Date
    2011-07-28
    2022-09-01
    ASK
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    • FDA
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    Raloxifene Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    27064
    Active
    RALOXIFENE HYDROCHLORIDE USP
    2013-05-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Raloxifene Hydrochloride (USP)
    2022-09-01
    Application Number
    27064
    Indian CDSCO WC-0074
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    RALOXIFENE HYDROCHLORIDE USP
    Raloxifene Hydrochloride (USP)
    Issue/Submission Date
    2013-05-06
    2022-09-01
    ASK
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    your Marketing & Sales content
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    • FDA
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    Venlafaxine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29718
    Active
    VENLAFAXINE HYDROCHLORIDE USP (PROC...
    2015-09-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-170 - Rev 01
    Valid
    Venlafaxine hydrochloride
    2014-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29718
    R1-CEP 2007-170 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VENLAFAXINE HYDROCHLORIDE USP (PROC...
    Venlafaxine hydrochloride
    Issue/Submission Date
    2015-09-23
    2014-06-20
    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

    Caution USDMF

    21960
    Inactive
    ATORVASTATIN CALCIUM
    2008-08-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Atorvastatin Calcium USP
    2022-09-01
    Application Number
    21960
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin Calcium USP
    Issue/Submission Date
    2008-08-26
    2022-09-01
    ASK
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    • FDA
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    Chlorhexidine

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

    See Less

    USDMF

    Caution USDMF

    16075
    Inactive
    CHLORHEXIDINE BASE
    2002-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10001
    Chlorhexidine at Sarkhej-Dholka Roa...
    2019-05-08
    Written Confirmation

    Close WC

    Application Number
    16075
    301MF10001
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORHEXIDINE BASE
    Chlorhexidine at Sarkhej-Dholka Roa...
    Issue/Submission Date
    2002-07-25
    2019-05-08
    ASK
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    your Marketing & Sales content
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    • FDA
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    Itopride Hydrochloride

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

    See Less

    USDMF

    Caution USDMF

    21190
    Inactive
    ITOPRIDE HYDROCHLORIDE
    2007-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Itopride HCL(IH)
    2022-09-01
    Application Number
    21190
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    ITOPRIDE HYDROCHLORIDE
    Itopride HCL(IH)
    Issue/Submission Date
    2007-11-28
    2022-09-01
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    • FDA
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    Nateglinide

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21962
    Inactive
    NATEGLINIDE FORM B
    2008-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Nateglinide (USP/ Ph. Eur.)_
    2022-09-01
    Application Number
    21962
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    NATEGLINIDE FORM B
    Nateglinide (USP/ Ph. Eur.)_
    Issue/Submission Date
    2008-09-09
    2022-09-01
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    • FDA
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    Ondansetron

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

    See Less

    USDMF

    Caution USDMF

    21027
    Inactive
    Ondansetron
    2007-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Ondansetron (USP)_
    2022-09-01
    Application Number
    21027
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    Ondansetron
    Ondansetron (USP)_
    Issue/Submission Date
    2007-10-29
    2022-09-01
    ASK
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    • FDA
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    Rabeprazole

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

    See Less

    USDMF

    Caution USDMF

    21034
    Inactive
    RABEPRAZOLE SODIUM
    2007-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Rabeprazole Sodium IH
    2022-09-01
    Application Number
    21034
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    RABEPRAZOLE SODIUM
    Rabeprazole Sodium IH
    Issue/Submission Date
    2007-10-30
    2022-09-01
    ASK
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    • FDA
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    Valsartan

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

    See Less

    USDMF

    Caution USDMF

    22183
    Inactive
    VALSARTAN
    2008-11-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Valsartan (USP)
    2022-09-01
    Application Number
    22183
    Indian CDSCO WC-0074
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    VALSARTAN
    Valsartan (USP)
    Issue/Submission Date
    2008-11-14
    2022-09-01
    ASK
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    • FDA
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    Zolpidem Tartrate

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

    See Less

    USDMF

    Caution USDMF

    18986
    Inactive
    ZOLPIDEM TARTRATE
    2005-08-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-222 - Rev 00
    Valid
    Zolpidem tartrate
    2014-07-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18986
    R1-CEP 2007-222 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ZOLPIDEM TARTRATE
    Zolpidem tartrate
    Issue/Submission Date
    2005-08-04
    2014-07-25
    ASK
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    • FDA
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    Aripiprazole

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

    See Less

    USDMF

    Found USDMF

    29680
    Active
    ARIPIPRAZOLE USP
    2015-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29680
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE USP
    Issue/Submission Date
    2015-09-11
    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

    28122
    Active
    ATORVASTATIN CALCIUM USP FORM-I
    2014-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28122
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ATORVASTATIN CALCIUM USP FORM-I
    Issue/Submission Date
    2014-04-16
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    Carvedilol

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    USDMF

    Found USDMF

    28139
    Active
    CARVEDILOL USP
    2014-04-18
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28139
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARVEDILOL USP
    Issue/Submission Date
    2014-04-18
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    Chlorhexidine Hydrochloride

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Chlorhexidine HCL (BP)/Chlorhexidin...
    2022-09-01
    Application Number
    Indian CDSCO WC-0074
    Status
     
    Valid
    2025-07-02
    Filing Details
    Chlorhexidine HCL (BP)/Chlorhexidin...
    Issue/Submission Date
    2022-09-01
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    Labetalol Hydrochloride

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    USDMF

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    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0074
    Valid
    Labetalol Hydrochloride USP
    2022-09-01
    Application Number
    Indian CDSCO WC-0074
    Status
     
    Valid
    2025-07-02
    Filing Details
    Labetalol Hydrochloride USP
    Issue/Submission Date
    2022-09-01
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    Loratadine

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    USDMF

    Found USDMF

    17582
    Active
    LORATADINE USP POWDER
    2004-07-10
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    17582
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LORATADINE USP POWDER
    Issue/Submission Date
    2004-07-10
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    Nateglinide

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    USDMF

    Found USDMF

    26518
    Active
    NATEGLINIDE FORM H USP
    2013-06-21
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    26518
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NATEGLINIDE FORM H USP
    Issue/Submission Date
    2013-06-21
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    Valsartan

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    USDMF

    Found USDMF

    26167
    Active
    VALSARTAN USP (PROCESS 2)
    2012-07-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26167
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VALSARTAN USP (PROCESS 2)
    Issue/Submission Date
    2012-07-07
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