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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Morepen Laboratories

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    Morepen Laboratories
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    Country
    Country
    India
    Address
    Address
    Morepen Laboratories Ltd., 2nd Floor, Tower C, DLF Cyber Park, Udyog Vihar, Sector -20, Gurgaon - 122016
    Telephone
    Telephone
    +91 1244892000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://morepen.com/
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    Linkedin
    https://in.linkedin.com/company/morepen-laboratories-limited-india
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    Loratadine

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    USDMF

    Found USDMF

    12650
    Active
    LORATADINE
    1997-09-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-348 - Rev 04
    Valid
    Loratadine, Milled, micronised
    2023-06-13
    Japanese DMF

    Found JDMF

    227MF10263
    Loratadine at 2nd Floor, Tower C, D...
    2015-11-11
    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Loratadine EP/USP
    2022-06-03
    Application Number
    12650
    R1-CEP 2007-348 - Rev 04
    227MF10263
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LORATADINE
    Loratadine, Milled, micronised
    Loratadine at 2nd Floor, Tower C, D...
    Loratadine EP/USP
    Issue/Submission Date
    1997-09-11
    2023-06-13
    2015-11-11
    2022-06-03
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    Atorvastatin

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    USDMF

    Caution USDMF

    18122
    Inactive
    ATORVASTATIN CALCIUM
    2005-02-23
    CEP/COS

    Found CEP/COS

    CEP 2012-179 - Rev 04
    Valid
    Atorvastatin calcium, Micronised
    2023-09-18
    Japanese DMF

    Found JDMF

    302MF10070
    Atorvastatin calcium hydrate at 4th...
    2020-06-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Atorvastatin Calcium Trihydrate EP/...
    2019-06-17
    Application Number
    18122
    CEP 2012-179 - Rev 04
    302MF10070
    Indian CDSCO WC-0050
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-16
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium, Micronised
    Atorvastatin calcium hydrate at 4th...
    Atorvastatin Calcium Trihydrate EP/...
    Issue/Submission Date
    2005-02-23
    2023-09-18
    2020-06-23
    2019-06-17
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    Desloratadine

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    USDMF

    Found USDMF

    17652
    Active
    DESLORATADINE
    2004-09-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-302 - Rev 00
    Valid
    Desloratadine, Milled, micronised
    2020-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Desloratidine USP/EP
    2022-06-03
    Application Number
    17652
    R1-CEP 2014-302 - Rev 00
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DESLORATADINE
    Desloratadine, Milled, micronised
    Desloratidine USP/EP
    Issue/Submission Date
    2004-09-07
    2020-10-19
    2022-06-03
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    Montelukast Sodium

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    USDMF

    Found USDMF

    24445
    Active
    MONTELUKAST SODIUM
    2010-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-003 - Rev 01
    Valid
    Montelukast sodium, Milled and micr...
    2022-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Montelukast Sodium USP/EP/BP
    2022-06-03
    Application Number
    24445
    R1-CEP 2012-003 - Rev 01
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MONTELUKAST SODIUM
    Montelukast sodium, Milled and micr...
    Montelukast Sodium USP/EP/BP
    Issue/Submission Date
    2010-12-13
    2022-08-19
    2022-06-03
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    • FDA
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    Rivaroxaban

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    USDMF

    Found USDMF

    36252
    Active
    RIVAROXABAN
    2021-08-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-369 - Rev 00
    Valid
    Rivaroxaban
    2023-01-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0050A
    Valid
    Rivaroxaban IH/EP
    2022-04-20
    Application Number
    36252
    R0-CEP 2021-369 - Rev 00
    Indian CDSCO WC-0050A
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-04-19
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban IH/EP
    Issue/Submission Date
    2021-08-28
    2023-01-16
    2022-04-20
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    Fexofenadine Hydrochloride

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    USDMF

    Found USDMF

    30692
    Active
    FEXOFENADINE HYDROCHLORIDE USP
    2016-06-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-256 - Rev 00
    Valid
    Fexofenadine hydrochloride
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Fexofenadine Hydrochloride (USP/EP)...
    2019-06-17
    Application Number
    30692
    R1-CEP 2015-256 - Rev 00
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP
    Fexofenadine hydrochloride
    Fexofenadine Hydrochloride (USP/EP)...
    Issue/Submission Date
    2016-06-27
    2021-09-16
    2019-06-17
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    32651
    Active
    ROSUVASTATIN CALCIUM PROCESS -2
    2018-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-153 - Rev 00
    Valid
    Rosuvastatin calcium, Process 2
    2023-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Rosuvastatin Calcium (EP)
    2019-06-17
    Application Number
    32651
    R1-CEP 2017-153 - Rev 00
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-16
    Filing Details
    ROSUVASTATIN CALCIUM PROCESS -2
    Rosuvastatin calcium, Process 2
    Rosuvastatin Calcium (EP)
    Issue/Submission Date
    2018-03-12
    2023-06-22
    2019-06-17
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    33348
    Active
    ROSUVASTATIN CALCIUM
    2018-11-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-309 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33348
    R1-CEP 2015-309 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium
    Issue/Submission Date
    2018-11-26
    2022-01-05
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    33517
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    2019-01-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-040 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2020-05-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33517
    R0-CEP 2019-040 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2019-01-17
    2020-05-12
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    Apixaban

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    35799
    Active
    APIXABAN
    2021-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050A4
    Expired
    Apixaban IH
    2021-12-24
    Application Number
    35799
    Indian CDSCO WC-0050A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2021-03-27
    2021-12-24
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    Dapagliflozin Propanediol Monohydrate

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    USDMF

    Found USDMF

    34690
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2020-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050A2
    Expired
    Dapagliflozin Propanediol Monohydra...
    2020-09-30
    Application Number
    34690
    Indian CDSCO WC-0050A2
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Dapagliflozin Propanediol Monohydra...
    Issue/Submission Date
    2020-03-18
    2020-09-30
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    Empagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33931
    Active
    EMPAGLIFLOZIN
    2019-07-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050a3
    Expired
    Empagliflozin IH
    2020-10-16
    Application Number
    33931
    Indian CDSCO WC-0050a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    EMPAGLIFLOZIN
    Empagliflozin IH
    Issue/Submission Date
    2019-07-06
    2020-10-16
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    Linagliptin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34162
    Active
    LINAGLIPTIN
    2019-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050a3
    Expired
    Linagliptin IH
    2020-10-16
    Application Number
    34162
    Indian CDSCO WC-0050a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    LINAGLIPTIN
    Linagliptin IH
    Issue/Submission Date
    2019-10-04
    2020-10-16
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    Loratadine

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    USDMF

    Found USDMF

    20669
    Active
    LORATADINE (PROCESS 2) U.S.P.
    2007-07-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Loratadine (USP/EP)
    2019-06-17
    Application Number
    20669
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-16
    Filing Details
    LORATADINE (PROCESS 2) U.S.P.
    Loratadine (USP/EP)
    Issue/Submission Date
    2007-07-11
    2019-06-17
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36555
    Active
    OLMESARTAN MEDOXOMIL
    2021-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Olmesartan Medoxomil (EP)
    2019-06-17
    Application Number
    36555
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    OLMESARTAN MEDOXOMIL
    Olmesartan Medoxomil (EP)
    Issue/Submission Date
    2021-12-02
    2019-06-17
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    Saxagliptin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33635
    Active
    SAXAGLIPTIN HYDROCHLORIDE
    2019-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Saxagliptin Hydrochloride IH
    2019-06-17
    Application Number
    33635
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    SAXAGLIPTIN HYDROCHLORIDE
    Saxagliptin Hydrochloride IH
    Issue/Submission Date
    2019-02-27
    2019-06-17
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    Saxagliptin Hydrochloride

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    USDMF

    Found USDMF

    35690
    Active
    SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
    2021-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050A4
    Expired
    Saxagliptin Hydrochloride dihydrate...
    2021-12-24
    Application Number
    35690
    Indian CDSCO WC-0050A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
    Saxagliptin Hydrochloride dihydrate...
    Issue/Submission Date
    2021-02-27
    2021-12-24
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35900
    Active
    APIXABAN FORM H3
    2021-05-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35900
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    APIXABAN FORM H3
    Issue/Submission Date
    2021-05-03
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    Apixaban

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    See Less

    USDMF

    Found USDMF

    36641
    Active
    APIXABAN AMORPHOUS
    2021-12-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36641
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    APIXABAN AMORPHOUS
    Issue/Submission Date
    2021-12-27
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    Atorvastatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26351
    Active
    ATORVASTATIN CALCIUM TRIHYDRATE
    2012-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26351
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ATORVASTATIN CALCIUM TRIHYDRATE
    Issue/Submission Date
    2012-08-23
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    Dapagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36898
    Active
    DAPAGLIFLOZIN AMORPHOUS
    2022-03-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36898
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DAPAGLIFLOZIN AMORPHOUS
    Issue/Submission Date
    2022-03-14
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    Edoxaban Tosylate

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    USDMF

    Found USDMF

    36084
    Active
    EDOXABAN TOSYLATE
    2021-07-02
    CEP/COS

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    Application Number
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    EDOXABAN TOSYLATE
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    37359
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    ERTUGLIFLOZIN L-PYROGLUTAMATE
    2022-07-26
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    Application Number
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    LINAGLIPTIN FORM C
    2021-08-18
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    Application Number
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    LINAGLIPTIN FORM C
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    35524
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    2020-12-31
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    Application Number
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    2023-01-05
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    Application Number
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    36753
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    2022-01-31
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    Application Number
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    VORTIOXETINE HYDROBROMIDE
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    18402
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    ATORVASTATIN CALCIUM AMORPHOUS, BUL...
    2005-06-06
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    Application Number
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    ATORVASTATIN CALCIUM AMORPHOUS, BUL...
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    Expired
    Candesartan Cilexetil USP/BP/EP
    2020-09-30
    Application Number
    Indian CDSCO WC-0050A2
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    Expired
    2022-06-16
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    Montelukast Sodium (USP/ EP)
    2019-06-17
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    Indian CDSCO WC-0050
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    Expired
    2022-06-16
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    17701
    Inactive
    PIOGLITAZONE HYDROCHLORIDE
    2004-09-23
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    Application Number
    17701
    Status
    Inactive
    Fees Paid
    N/A
     
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    PIOGLITAZONE HYDROCHLORIDE
    Issue/Submission Date
    2004-09-23
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    Indian CDSCO WC-0050A4
    Expired
    Rivaroxaban IH
    2021-12-24
    Application Number
    Indian CDSCO WC-0050A4
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    Expired
    2022-06-16
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    Rivaroxaban IH
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    2021-12-24
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