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    CTX Lifesciences
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    India
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    Block No. 251-252, Sachin Magdalla Road, G.I.D.C, Sachin, Surat - 394230, Gujarat
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    +91-261-239845
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    enquiries@pharmacompass.com
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    Acetazolamide

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    USDMF

    Found USDMF

    23014
    Active
    ACETAZOLAMIDE USP
    2009-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-073 - Rev 03
    Valid
    Acetazolamide
    2022-11-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Acetazolamide(Ph. Eur.)
    2022-06-24
    Application Number
    23014
    R1-CEP 2010-073 - Rev 03
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ACETAZOLAMIDE USP
    Acetazolamide
    Acetazolamide(Ph. Eur.)
    Issue/Submission Date
    2009-07-31
    2022-11-14
    2022-06-24
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    Amiodarone Hydrochloride

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    USDMF

    Found USDMF

    25892
    Active
    AMIODARONE HYDROCHLORIDE USP
    2012-04-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-129 - Rev 01
    Valid
    Amiodarone hydrochloride
    2021-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Amiodarone Hydrochloride(Ph. Eur.)
    2022-06-24
    Application Number
    25892
    R1-CEP 2009-129 - Rev 01
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    AMIODARONE HYDROCHLORIDE USP
    Amiodarone hydrochloride
    Amiodarone Hydrochloride(Ph. Eur.)
    Issue/Submission Date
    2012-04-09
    2021-03-25
    2022-06-24
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    • FDA
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    Carbamazepine

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    USDMF

    Found USDMF

    24195
    Active
    CARBAMAZEPINE USP
    2010-09-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-149 - Rev 00
    Valid
    Carbamazepine
    2020-11-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Carbamazepine(Ph. Eur.)
    2022-06-24
    Application Number
    24195
    R1-CEP 2014-149 - Rev 00
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CARBAMAZEPINE USP
    Carbamazepine
    Carbamazepine(Ph. Eur.)
    Issue/Submission Date
    2010-09-17
    2020-11-09
    2022-06-24
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    Carvedilol

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    USDMF

    Found USDMF

    24096
    Active
    CARVEDILOL (ROUTE-II)
    2010-08-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-201 - Rev 01
    Valid
    Carvedilol
    2022-04-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Carvedilol USP/EP/BP
    2022-06-24
    Application Number
    24096
    R1-CEP 2014-201 - Rev 01
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    CARVEDILOL (ROUTE-II)
    Carvedilol
    Carvedilol USP/EP/BP
    Issue/Submission Date
    2010-08-12
    2022-04-05
    2022-06-24
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    • FDA
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    21039
    Active
    HYDROCHLOROTHIAZIDE USP
    2007-11-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-021 - Rev 05
    Valid
    Hydrochlorothiazide
    2023-08-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Hydrochlorothiazide (Ph. Eur)
    2022-06-24
    Application Number
    21039
    R1-CEP 2008-021 - Rev 05
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    HYDROCHLOROTHIAZIDE USP
    Hydrochlorothiazide
    Hydrochlorothiazide (Ph. Eur)
    Issue/Submission Date
    2007-11-04
    2023-08-29
    2022-06-24
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    Irbesartan

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    USDMF

    Found USDMF

    24596
    Active
    IRBESARTAN USP
    2011-04-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-139 - Rev 05
    Valid
    Irbesartan
    2023-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Irbesartan(Ph. Eur.)
    2022-06-24
    Application Number
    24596
    R1-CEP 2011-139 - Rev 05
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    IRBESARTAN USP
    Irbesartan
    Irbesartan(Ph. Eur.)
    Issue/Submission Date
    2011-04-19
    2023-06-16
    2022-06-24
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    Lamotrigine

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    USDMF

    Found USDMF

    24958
    Active
    LAMOTRIGINE USP
    2011-06-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-168 - Rev 02
    Valid
    Lamotrigine
    2021-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Lamotrigine(Ph. Eur.)
    2022-06-24
    Application Number
    24958
    R1-CEP 2011-168 - Rev 02
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Lamotrigine(Ph. Eur.)
    Issue/Submission Date
    2011-06-06
    2021-01-26
    2022-06-24
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    • FDA
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    Mesalazine

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    USDMF

    Found USDMF

    29051
    Active
    MESALAMINE USP
    2015-02-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-152 - Rev 00
    Valid
    Mesalazine
    2021-06-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Mesalamine USP/Mesalazine EP
    2022-06-24
    Application Number
    29051
    R1-CEP 2015-152 - Rev 00
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MESALAMINE USP
    Mesalazine
    Mesalamine USP/Mesalazine EP
    Issue/Submission Date
    2015-02-20
    2021-06-09
    2022-06-24
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    Metoprolol Succinate

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    USDMF

    Found USDMF

    21732
    Active
    METOPROLOL SUCCINATE USP
    2008-06-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-198 - Rev 03
    Valid
    Metoprolol succinate
    2018-04-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Metoprolol Succinate(Ph. Eur.)
    2022-06-24
    Application Number
    21732
    R1-CEP 2008-198 - Rev 03
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METOPROLOL SUCCINATE USP
    Metoprolol succinate
    Metoprolol Succinate(Ph. Eur.)
    Issue/Submission Date
    2008-06-14
    2018-04-03
    2022-06-24
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    Metoprolol Tartrate

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    USDMF

    Found USDMF

    21347
    Active
    METOPROLOL TARTRATE USP
    2008-02-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-260 - Rev 02
    Valid
    Metoprolol tartrate, Route I
    2018-04-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Metoprolol Tartrate(Ph. Eur.)
    2022-06-24
    Application Number
    21347
    R1-CEP 2009-260 - Rev 02
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METOPROLOL TARTRATE USP
    Metoprolol tartrate, Route I
    Metoprolol Tartrate(Ph. Eur.)
    Issue/Submission Date
    2008-02-01
    2018-04-04
    2022-06-24
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    • FDA
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    Oxcarbazepine

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    USDMF

    Found USDMF

    23353
    Active
    OXCARBAZEPINE
    2009-11-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-113 - Rev 01
    Valid
    Oxcarbazepine
    2023-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Oxcarbazepine (IH)
    2022-06-24
    Application Number
    23353
    R0-CEP 2018-113 - Rev 01
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    OXCARBAZEPINE
    Oxcarbazepine
    Oxcarbazepine (IH)
    Issue/Submission Date
    2009-11-30
    2023-01-17
    2022-06-24
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    Oxymetazoline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22401
    Active
    OXYMETAZOLINE HYDROCHLORIDE USP
    2008-12-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-324 - Rev 03
    Valid
    Oxymetazoline hydrochloride
    2018-05-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Oxymetazoline HCI (Ph. Eur.)
    2022-06-24
    Application Number
    22401
    R1-CEP 2008-324 - Rev 03
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    OXYMETAZOLINE HYDROCHLORIDE USP
    Oxymetazoline hydrochloride
    Oxymetazoline HCI (Ph. Eur.)
    Issue/Submission Date
    2008-12-10
    2018-05-18
    2022-06-24
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    Pregabalin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26246
    Active
    PREGABALIN
    2012-07-31
    CEP/COS

    Found CEP/COS

    CEP 2016-328 - Rev 04
    Valid
    Pregabalin
    2023-12-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Pregabalin (IH)
    2022-06-24
    Application Number
    26246
    CEP 2016-328 - Rev 04
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin (IH)
    Issue/Submission Date
    2012-07-31
    2023-12-15
    2022-06-24
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    39279
    Active
    ROSUVASTATIN CALCIUM USP
    2023-12-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-060 - Rev 00
    Valid
    Rosuvastatin calcium, RS01
    2023-05-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Rosuvastatin Calcium IH/IP
    2022-06-24
    Application Number
    39279
    R0-CEP 2023-060 - Rev 00
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ROSUVASTATIN CALCIUM USP
    Rosuvastatin calcium, RS01
    Rosuvastatin Calcium IH/IP
    Issue/Submission Date
    2023-12-21
    2023-05-22
    2022-06-24
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    • FDA
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    Xylometazoline Hydrochloride

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    USDMF

    Found USDMF

    22045
    Active
    XYLOMETAZOLINE HYDROCHLORIDE USP
    2008-09-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-255 - Rev 02
    Valid
    Xylometazoline hydrochloride
    2017-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Xylometazoline HCI (Ph. Eur.)
    2022-06-24
    Application Number
    22045
    R1-CEP 2008-255 - Rev 02
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    XYLOMETAZOLINE HYDROCHLORIDE USP
    Xylometazoline hydrochloride
    Xylometazoline HCI (Ph. Eur.)
    Issue/Submission Date
    2008-09-19
    2017-09-18
    2022-06-24
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    Deferasirox

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    30213
    Inactive
    DEFERASIROX
    2016-01-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-493 - Rev 00
    Valid
    Deferasirox
    2023-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Deferasirox IH
    2022-06-24
    Application Number
    30213
    R0-CEP 2021-493 - Rev 00
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DEFERASIROX
    Deferasirox
    Deferasirox IH
    Issue/Submission Date
    2016-01-27
    2023-07-12
    2022-06-24
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    Amisulpride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-167 - Rev 00
    Valid
    Amisulpride
    2023-08-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Amisulpride EP/BP
    2022-06-24
    Application Number
    R0-CEP 2022-167 - Rev 00
    Indian CDSCO WC-0097
    Status
    Valid
     
    Valid
    2025-07-02
    Filing Details
    Amisulpride
    Amisulpride EP/BP
    Issue/Submission Date
    2023-08-03
    2022-06-24
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    Chlorothiazide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23015
    Active
    CHLOROTHIAZIDE USP
    2009-07-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Chlorothiazide EP/USP
    2022-06-24
    Application Number
    23015
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CHLOROTHIAZIDE USP
    Chlorothiazide EP/USP
    Issue/Submission Date
    2009-07-23
    2022-06-24
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    Chlorthalidone

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    USDMF

    Found USDMF

    39142
    Active
    CHLORTHALIDONE USP
    2023-12-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-392 - Rev 00
    Valid
    Chlortalidone
    2023-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39142
    R0-CEP 2021-392 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CHLORTHALIDONE USP
    Chlortalidone
    Issue/Submission Date
    2023-12-05
    2023-01-13
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    • FDA
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    Eslicarbazepine Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30222
    Active
    ESLICARBAZEPINE ACETATE
    2016-01-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Eslicarbazepine Acetate IH
    2022-06-24
    Application Number
    30222
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ESLICARBAZEPINE ACETATE
    Eslicarbazepine Acetate IH
    Issue/Submission Date
    2016-01-29
    2022-06-24
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    Ticagrelor

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    USDMF

    Found USDMF

    38658
    Active
    TICAGRELOR
    2023-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Ticagrelor IH
    2022-06-24
    Application Number
    38658
    Indian CDSCO WC-0097
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TICAGRELOR
    Ticagrelor IH
    Issue/Submission Date
    2023-07-31
    2022-06-24
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    Duloxetine

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    USDMF

    Caution USDMF

    29540
    Inactive
    DULOXETINE HYDROCHLORIDE USP
    2015-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Duloxetine Hydrochloride EP/ USP
    2022-06-24
    Application Number
    29540
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    DULOXETINE HYDROCHLORIDE USP
    Duloxetine Hydrochloride EP/ USP
    Issue/Submission Date
    2015-07-29
    2022-06-24
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    26198
    Inactive
    OLMESARTAN MEDOXOMIL
    2012-07-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Olmesartan Medoxomil(Ph. Eur.)
    2022-06-24
    Application Number
    26198
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    OLMESARTAN MEDOXOMIL
    Olmesartan Medoxomil(Ph. Eur.)
    Issue/Submission Date
    2012-07-10
    2022-06-24
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    Oxcarbazepine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34102
    Active
    OXCARBAZEPINE USP
    2019-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Oxcarbazepine EP/USP
    2019-09-27
    Application Number
    34102
    Indian CDSCO WC-0097A3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    OXCARBAZEPINE USP
    Oxcarbazepine EP/USP
    Issue/Submission Date
    2019-08-28
    2019-09-27
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    Rosuvastatin Calcium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-412 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-11-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Rosuvastatin Calcium EP
    2019-09-27
    Application Number
    R0-CEP 2020-412 - Rev 00
    Indian CDSCO WC-0097A3
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Rosuvastatin calcium
    Rosuvastatin Calcium EP
    Issue/Submission Date
    2022-11-28
    2019-09-27
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    Sevelamer Carbonate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    28299
    Inactive
    SEVELAMER CARBONATE
    2014-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Sevelamer Carbonate IH
    2022-06-24
    Application Number
    28299
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    SEVELAMER CARBONATE
    Sevelamer Carbonate IH
    Issue/Submission Date
    2014-05-28
    2022-06-24
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    Sevelamer Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    27491
    Inactive
    SEVELAMER HYDROCHLORIDE
    2013-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Sevelamer Hydrochloride IH
    2022-06-24
    Application Number
    27491
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    SEVELAMER HYDROCHLORIDE
    Sevelamer Hydrochloride IH
    Issue/Submission Date
    2013-09-27
    2022-06-24
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    Terazosin HCl

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25829
    Inactive
    TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
    2012-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Terazosin Hydrochloride Dihydrate U...
    2022-06-24
    Application Number
    25829
    Indian CDSCO WC-0097
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TERAZOSIN HYDROCHLORIDE DIHYDRATE U...
    Terazosin Hydrochloride Dihydrate U...
    Issue/Submission Date
    2012-03-24
    2022-06-24
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    4-Biphenylacetic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10173
    Felbinac at Block #251-252, Sachin ...
    2011-12-22
    Written Confirmation

    Close WC

    Application Number
    223MF10173
    Status
     
    Filing Details
    Felbinac at Block #251-252, Sachin ...
    Issue/Submission Date
    2011-12-22
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    Alogliptin Benzoate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Alogliptin Benzoate IH
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Alogliptin Benzoate IH
    Issue/Submission Date
    2022-06-24
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Apixaban IH
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Apixaban IH
    Issue/Submission Date
    2022-06-24
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    Azilsartan

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Azilsartan Medoxomil Potassium IH
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Azilsartan Medoxomil Potassium IH
    Issue/Submission Date
    2022-06-24
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    Deferasirox

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38963
    Active
    DEFERASIROX
    2023-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38963
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEFERASIROX
    Issue/Submission Date
    2023-10-25
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    Lercanidipine HCl

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Lercanidipine HCl IP
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Lercanidipine HCl IP
    Issue/Submission Date
    2022-06-24
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    Metoprolol Tartrate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    22936
    Inactive
    METOPROLOL TARTRATE USP (ROUTE-I)
    2009-06-25
    CEP/COS

    Caution CEP/COS

    R0-CEP 2008-242 - Rev 00
    Withdrawn by Holder
    Metoprolol tartrate
    2009-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22936
    R0-CEP 2008-242 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    METOPROLOL TARTRATE USP (ROUTE-I)
    Metoprolol tartrate
    Issue/Submission Date
    2009-06-25
    2009-10-15
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    Ondansetron Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Ondansetron Hydrochloride Dihydrate...
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Ondansetron Hydrochloride Dihydrate...
    Issue/Submission Date
    2022-06-24
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    Propranolol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Propranolol Hydrochloride EP/USP
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Propranolol Hydrochloride EP/USP
    Issue/Submission Date
    2022-06-24
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    Saxagliptin Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0097
    Valid
    Saxagliptin Hydrochloride Dihydrate...
    2022-06-24
    Application Number
    Indian CDSCO WC-0097
    Status
     
    Valid
    2025-07-02
    Filing Details
    Saxagliptin Hydrochloride Dihydrate...
    Issue/Submission Date
    2022-06-24
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    Alendronate Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25828
    Inactive
    ALENDRONATE SODIUM USP
    2012-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25828
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALENDRONATE SODIUM USP
    Issue/Submission Date
    2012-03-24
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    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Apixaban IH
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Apixaban IH
    Issue/Submission Date
    2019-09-27
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    Azilsartan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Azilsartan Medoxomil Potassium IH
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Azilsartan Medoxomil Potassium IH
    Issue/Submission Date
    2019-09-27
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    Colesevelam Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    27492
    Inactive
    COLESEVELAM HYDROCHLORIDE
    2013-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27492
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    COLESEVELAM HYDROCHLORIDE
    Issue/Submission Date
    2013-09-27
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    Irbesartan

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Irbesartan USP
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Irbesartan USP
    Issue/Submission Date
    2019-09-27
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    Levetiracetam

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    27458
    Inactive
    LEVETIRACETAM
    2013-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27458
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    LEVETIRACETAM
    Issue/Submission Date
    2013-09-06
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    Pregabalin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Pregabalin EP/USP
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Pregabalin EP/USP
    Issue/Submission Date
    2019-09-27
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    Propranolol Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Propranolol Hydrochloride EP/USP
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Propranolol Hydrochloride EP/USP
    Issue/Submission Date
    2019-09-27
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    • FDA
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    Saxagliptin Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0097A3
    Expired
    Saxagliptin Hydrochloride Dihydrate
    2019-09-27
    Application Number
    Indian CDSCO WC-0097A3
    Status
     
    Expired
    2022-07-02
    Filing Details
    Saxagliptin Hydrochloride Dihydrate
    Issue/Submission Date
    2019-09-27
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