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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dishman Carbogen Amcis

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    Dishman Carbogen Amcis
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    India
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    Address
    Dishman Corporate House Iscon-Bopal Road, Ambli Ahmedabad - 380058 Gujarat
    Telephone
    Telephone
    +91 2717 420 100
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    enquiries@pharmacompass.com
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    https://imdcal.com/
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    Omeprazole

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    USDMF

    Found USDMF

    23219
    Active
    OMEPRAZOLE
    2009-10-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10050
    Omeprazole at Bhadr-Raj Chambers, S...
    2011-04-12
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Omeprazole BP/EP/IH
    2019-12-03
    Application Number
    23219
    223MF10050
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    OMEPRAZOLE
    Omeprazole at Bhadr-Raj Chambers, S...
    Omeprazole BP/EP/IH
    Issue/Submission Date
    2009-10-20
    2011-04-12
    2019-12-03
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    Sodium Picosulfate

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    USDMF

    Caution USDMF

    27646
    Inactive
    SODIUM PICOSULFATE
    2013-10-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-021 - Rev 00
    Valid
    Sodium picosulfate
    2020-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0136
    Valid
    Sodium Picosulfate (BP/JP/EP)
    2022-09-16
    Application Number
    27646
    R0-CEP 2020-021 - Rev 00
    Indian CDSCO WC-0136
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-22
    Filing Details
    SODIUM PICOSULFATE
    Sodium picosulfate
    Sodium Picosulfate (BP/JP/EP)
    Issue/Submission Date
    2013-10-17
    2020-12-14
    2022-09-16
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    • FDA
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    Benzethonium Chloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10110
    Benzethonium chloride at Bhadr-Raj ...
    2011-07-15
    Written Confirmation

    Found WC

    Indian CDSCO WC-0136
    Valid
    Benzethonium Chloride (USP)
    2022-09-16
    Application Number
    223MF10110
    Indian CDSCO WC-0136
    Status
     
    Valid
    2025-07-22
    Filing Details
    Benzethonium chloride at Bhadr-Raj ...
    Benzethonium Chloride (USP)
    Issue/Submission Date
    2011-07-15
    2022-09-16
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    Bisacodyl

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    USDMF

    Found USDMF

    20476
    Active
    BISACODYL
    2007-04-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0136
    Valid
    Bisacodyl (BP/USP/EP)
    2022-09-16
    Application Number
    20476
    Indian CDSCO WC-0136
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-22
    Filing Details
    BISACODYL
    Bisacodyl (BP/USP/EP)
    Issue/Submission Date
    2007-04-24
    2022-09-16
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    • FDA
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    Cetrimide

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    USDMF

    Found USDMF

    35282
    Active
    CETRIMIDE
    2020-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0136
    Valid
    Cetrimide BP/EP
    2022-09-16
    Application Number
    35282
    Indian CDSCO WC-0136
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-22
    Filing Details
    CETRIMIDE
    Cetrimide BP/EP
    Issue/Submission Date
    2020-11-02
    2022-09-16
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    Cetylpyridinium Chloride

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    USDMF

    Found USDMF

    20349
    Active
    CETYLPYRIDINIUM CHLORIDE
    2007-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0136
    Valid
    Cetylpyridinium Chloride (BP/USP/EP...
    2022-09-16
    Application Number
    20349
    Indian CDSCO WC-0136
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-22
    Filing Details
    CETYLPYRIDINIUM CHLORIDE
    Cetylpyridinium Chloride (BP/USP/EP...
    Issue/Submission Date
    2007-03-16
    2022-09-16
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    • FDA
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    Nepafenac

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17812
    Active
    NEPAFENAC
    2004-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10160
    Nepafenac at Hauptstrasse 171, CH-4...
    2010-05-31
    Written Confirmation

    Close WC

    Application Number
    17812
    222MF10160
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NEPAFENAC
    Nepafenac at Hauptstrasse 171, CH-4...
    Issue/Submission Date
    2004-11-03
    2010-05-31
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    Vitamin D3

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    USDMF

    Found USDMF

    21380
    Active
    CHOLECALCIFEROL
    2008-02-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-347 - Rev 00
    Valid
    Cholecalciferol concentrate (oily f...
    2014-07-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21380
    R1-CEP 2007-347 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CHOLECALCIFEROL
    Cholecalciferol concentrate (oily f...
    Issue/Submission Date
    2008-02-25
    2014-07-18
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    Bupivacaine Hydrochloride

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    USDMF

    Found USDMF

    20959
    Active
    BUPIVACAINE HYDROCHLORIDE
    2007-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Bupivacaine Hydrochloride BP/USP/EP
    2019-12-03
    Application Number
    20959
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-21
    Filing Details
    BUPIVACAINE HYDROCHLORIDE
    Bupivacaine Hydrochloride BP/USP/EP
    Issue/Submission Date
    2007-10-18
    2019-12-03
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    26179
    Active
    CETIRIZINE HYDROCHLORIDE
    2012-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC0135A4
    Expired
    Cetrizine HCl BP/EP/USP
    2019-10-04
    Application Number
    26179
    Indian CDSCO WC0135A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    CETIRIZINE HYDROCHLORIDE
    Cetrizine HCl BP/EP/USP
    Issue/Submission Date
    2012-06-25
    2019-10-04
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    Chlorhexidine Gluconate

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    USDMF

    Found USDMF

    33238
    Active
    CHLORHEXIDINE GLUCONATE SOLUTION
    2018-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0137
    Expired
    Chlorhexidine Digluconate Solution ...
    2016-07-19
    Application Number
    33238
    Indian CDSCO WC-0137
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2019-07-02
    Filing Details
    CHLORHEXIDINE GLUCONATE SOLUTION
    Chlorhexidine Digluconate Solution ...
    Issue/Submission Date
    2018-10-21
    2016-07-19
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    Cinacalcet Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28640
    Active
    CINACALCET HYDROCHLORIDE
    2014-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Cinacalcet Hydrochloride IH
    2019-12-03
    Application Number
    28640
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    CINACALCET HYDROCHLORIDE
    Cinacalcet Hydrochloride IH
    Issue/Submission Date
    2014-09-15
    2019-12-03
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    Eprosartan Mesylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18155
    Active
    EPROSARTAN MESYLATE
    2005-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135
    Expired
    Eprosartan Mesylate IH
    2019-07-22
    Application Number
    18155
    Indian CDSCO WC-0135
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    EPROSARTAN MESYLATE
    Eprosartan Mesylate IH
    Issue/Submission Date
    2005-03-07
    2019-07-22
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    • FDA
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    Glimepiride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23005
    Active
    GLIMEPIRIDE
    2009-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Glimepiride BP/USP/EP
    2019-12-03
    Application Number
    23005
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    GLIMEPIRIDE
    Glimepiride BP/USP/EP
    Issue/Submission Date
    2009-07-27
    2019-12-03
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    Hexetidine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24162
    Inactive
    HEXETIDINE
    2010-09-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-238 - Rev 00
    Withdrawn by Holder
    Hexetidine
    2012-09-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135
    Expired
    Hexetidine Ph.Eur
    2019-07-22
    Application Number
    24162
    R0-CEP 2010-238 - Rev 00
    Indian CDSCO WC-0135
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-02
    Filing Details
    HEXETIDINE
    Hexetidine
    Hexetidine Ph.Eur
    Issue/Submission Date
    2010-09-07
    2012-09-10
    2019-07-22
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    Indapamide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    22388
    Inactive
    INDAPAMIDE
    2009-01-06
    CEP/COS

    Caution CEP/COS

    R1-CEP 2008-163 - Rev 00
    Withdrawn by Holder
    Indapamide
    2015-02-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Indapamide BP/USP/EP
    2019-12-03
    Application Number
    22388
    R1-CEP 2008-163 - Rev 00
    Indian CDSCO WC-0135A
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-21
    Filing Details
    INDAPAMIDE
    Indapamide
    Indapamide BP/USP/EP
    Issue/Submission Date
    2009-01-06
    2015-02-19
    2019-12-03
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    Octenidine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23075
    Active
    OCTENIDINE HYDROCHLORIDE
    2009-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135
    Expired
    Octenidine Hydrochloride IH
    2019-07-22
    Application Number
    23075
    Indian CDSCO WC-0135
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    OCTENIDINE HYDROCHLORIDE
    Octenidine Hydrochloride IH
    Issue/Submission Date
    2009-08-20
    2019-07-22
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24313
    Inactive
    PANTOPRAZOLE SODIUM
    2010-10-18
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-295 - Rev 00
    Withdrawn by Holder
    Pantoprazole sodium sesquihydrate
    2013-02-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Pantoprazole Sodium EP
    2019-12-03
    Application Number
    24313
    R0-CEP 2010-295 - Rev 00
    Indian CDSCO WC-0135A
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2022-07-21
    Filing Details
    PANTOPRAZOLE SODIUM
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium EP
    Issue/Submission Date
    2010-10-18
    2013-02-13
    2019-12-03
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    Pralidoxime Chloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21307
    Active
    PRALIDOXIME CHLORIDE
    2008-02-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Pralidoxime Chloride EP
    2019-12-03
    Application Number
    21307
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    PRALIDOXIME CHLORIDE
    Pralidoxime Chloride EP
    Issue/Submission Date
    2008-02-04
    2019-12-03
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    Ropivacaine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22023
    Active
    ROPIVACAINE HYDROCHLORIDE ANHYDROUS
    2008-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Ropivacaine HCl Monohydrate EP
    2019-12-03
    Application Number
    22023
    Indian CDSCO WC-0135A
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    ROPIVACAINE HYDROCHLORIDE ANHYDROUS
    Ropivacaine HCl Monohydrate EP
    Issue/Submission Date
    2008-09-22
    2019-12-03
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    Ropivacaine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25506
    Active
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    2011-11-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135
    Expired
    Ropivacaine Hydrochloride MonoHydra...
    2019-07-22
    Application Number
    25506
    Indian CDSCO WC-0135
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ROPIVACAINE HYDROCHLORIDE MONOHYDRA...
    Ropivacaine Hydrochloride MonoHydra...
    Issue/Submission Date
    2011-11-14
    2019-07-22
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    Tropicamide

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    6006
    Inactive
    TROPICAMIDE
    1985-09-09
    CEP/COS

    Found CEP/COS

    CEP 1998-077 - Rev 10
    Valid
    Tropicamide
    2024-02-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6006
    CEP 1998-077 - Rev 10
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TROPICAMIDE
    Tropicamide
    Issue/Submission Date
    1985-09-09
    2024-02-02
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    Alfacalcidol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-097 - Rev 09
    Valid
    Alfacalcidol
    2023-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-097 - Rev 09
    Status
    Valid
     
    Filing Details
    Alfacalcidol
    Issue/Submission Date
    2023-03-15
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    Atovaquone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26245
    Active
    TRANS CHLOROATOVAQUONE
    2012-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26245
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRANS CHLOROATOVAQUONE
    Issue/Submission Date
    2012-07-23
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    Benzocaine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    24523
    Inactive
    BENZOCAINE
    2010-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC0135A4
    Expired
    Benzocaine BP/EP/USP
    2019-10-04
    Application Number
    24523
    Indian CDSCO WC0135A4
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    BENZOCAINE
    Benzocaine BP/EP/USP
    Issue/Submission Date
    2010-12-15
    2019-10-04
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    Benzyldimethyltridecylazanium Chloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-152 - Rev 03
    Valid
    Benzalkonium chloride solution
    2020-12-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-152 - Rev 03
    Status
    Valid
     
    Filing Details
    Benzalkonium chloride solution
    Issue/Submission Date
    2020-12-03
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    Bisacodyl

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-163 - Rev 03
    Valid
    Bisacodyl
    2023-03-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-163 - Rev 03
    Status
    Valid
     
    Filing Details
    Bisacodyl
    Issue/Submission Date
    2023-03-16
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    Bupivacaine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32369
    Active
    BUPIVACAINE
    2017-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32369
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPIVACAINE
    Issue/Submission Date
    2017-12-22
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    Calcifediol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21963
    Active
    CALCIFEDIOL
    2008-09-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21963
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CALCIFEDIOL
    Issue/Submission Date
    2008-09-05
    ASK
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    Calcifediol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1998-059 - Rev 08
    Valid
    Calcifediol monohydrate
    2022-01-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-059 - Rev 08
    Status
    Valid
     
    Filing Details
    Calcifediol monohydrate
    Issue/Submission Date
    2022-01-07
    ASK
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    Calcitriol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14093
    Active
    CALCITRIOL
    1999-04-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14093
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CALCITRIOL
    Issue/Submission Date
    1999-04-16
    ASK
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    CAS 582-52-5

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32839
    Active
    DIACETONE FRUCTOSE
    2018-05-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32839
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIACETONE FRUCTOSE
    Issue/Submission Date
    2018-05-23
    ASK
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    Cetrimide

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-199 - Rev 02
    Valid
    Cetrimide
    2022-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-199 - Rev 02
    Status
    Valid
     
    Filing Details
    Cetrimide
    Issue/Submission Date
    2022-06-22
    ASK
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    Cetylpyridinium Chloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2007-029 - Rev 06
    Valid
    Cetylpyridinium Chloride
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2007-029 - Rev 06
    Status
    Valid
     
    Filing Details
    Cetylpyridinium Chloride
    Issue/Submission Date
    2023-11-08
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    Cholesterol

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

    See Less

    USDMF

    Found USDMF

    14346
    Active
    CHOLESTEROL HP
    1999-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14346
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHOLESTEROL HP
    Issue/Submission Date
    1999-08-03
    ASK
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    Cholesterol

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25382
    Active
    CHOLESTEROL HP
    2011-10-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25382
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHOLESTEROL HP
    Issue/Submission Date
    2011-10-12
    ASK
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    Cholesterol

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-148 - Rev 02
    Valid
    Cholesterol, NF
    2019-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-148 - Rev 02
    Status
    Valid
     
    Filing Details
    Cholesterol, NF
    Issue/Submission Date
    2019-01-17
    ASK
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    Cholesterol

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-199 - Rev 04
    Valid
    Cholesterol, HP
    2019-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-199 - Rev 04
    Status
    Valid
     
    Filing Details
    Cholesterol, HP
    Issue/Submission Date
    2019-01-17
    ASK
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    • FDA
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    Dihydrotachysterol

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

    See Less

    USDMF

    Found USDMF

    4691
    Active
    DIHYDROTACHYSTEROL
    1982-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4691
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DIHYDROTACHYSTEROL
    Issue/Submission Date
    1982-10-19
    ASK
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    Eprosartan Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    16703
    Inactive
    EPROSARTAN MESYLATE
    2003-07-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Eprosartan Mesylate IH
    2019-12-03
    Application Number
    16703
    Indian CDSCO WC-0135A
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    EPROSARTAN MESYLATE
    Eprosartan Mesylate IH
    Issue/Submission Date
    2003-07-14
    2019-12-03
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    Gemcitabine

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

    See Less

    USDMF

    Caution USDMF

    27649
    Inactive
    GEMCITABINE HYDROCHLORIDE
    2013-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Gemcitabine Hydrochloride BP/USP/EP
    2019-12-03
    Application Number
    27649
    Indian CDSCO WC-0135A
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    GEMCITABINE HYDROCHLORIDE
    Gemcitabine Hydrochloride BP/USP/EP
    Issue/Submission Date
    2013-10-21
    2019-12-03
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    Indigo Carmine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32702
    Active
    INDIGOTINDISULFONATE SODIUM
    2018-05-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32702
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INDIGOTINDISULFONATE SODIUM
    Issue/Submission Date
    2018-05-14
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    Indigo Carmine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32910
    Active
    INDIGOTINDISULFONATE SODIUM USP
    2018-06-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32910
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    INDIGOTINDISULFONATE SODIUM USP
    Issue/Submission Date
    2018-06-14
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    Isosulfan Blue

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    31226
    Active
    ISOSULFAN BLUE
    2016-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31226
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ISOSULFAN BLUE
    Issue/Submission Date
    2016-12-06
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    Levobupivacaine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33982
    Active
    LEVOBUPIVACAINE
    2019-08-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33982
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVOBUPIVACAINE
    Issue/Submission Date
    2019-08-20
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    Paricalcitol

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25300
    Active
    PARICALCITOL
    2011-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25300
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PARICALCITOL
    Issue/Submission Date
    2011-09-13
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    Quetiapine Hemifumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    24761
    Inactive
    QUETIAPINE FUMARATE
    2011-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC0135A4
    Expired
    Quetiapine Fumarate IH
    2019-10-04
    Application Number
    24761
    Indian CDSCO WC0135A4
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate IH
    Issue/Submission Date
    2011-03-07
    2019-10-04
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    Tramadol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    15630
    Inactive
    TRAMADOL HYDROCHLORIDE
    2001-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0135A
    Expired
    Tramodol Hcl EP
    2019-12-03
    Application Number
    15630
    Indian CDSCO WC-0135A
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    TRAMADOL HYDROCHLORIDE
    Tramodol Hcl EP
    Issue/Submission Date
    2001-09-20
    2019-12-03
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    Vitamin D3

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    34148
    Active
    CHOLECALCIFEROL USP
    2019-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34148
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHOLECALCIFEROL USP
    Issue/Submission Date
    2019-12-17
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    SGD-5088-TFA

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32004
    Active
    SGD-5088-TFA
    2017-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32004
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SGD-5088-TFA
    Issue/Submission Date
    2017-08-28
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