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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shilpa Medicare

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    Shilpa Medicare
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    India
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    1st Floor, 10/80, Rajendra Gunj, RAICHUR - 584 102 Karnataka
    Telephone
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    +91-8532-236494
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    • FDA
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    Busulfan

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    USDMF

    Found USDMF

    25491
    Active
    BUSULFAN USP
    2011-12-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-339 - Rev 02
    Valid
    Busulfan
    2022-07-20
    Japanese DMF

    Found JDMF

    230MF10027
    Busulfan at Shilpa House, #12-6-214...
    2018-02-15
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Busulfan (Ph.Eur/USP)
    2019-07-05
    Application Number
    25491
    R1-CEP 2011-339 - Rev 02
    230MF10027
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    BUSULFAN USP
    Busulfan
    Busulfan at Shilpa House, #12-6-214...
    Busulfan (Ph.Eur/USP)
    Issue/Submission Date
    2011-12-07
    2022-07-20
    2018-02-15
    2019-07-05
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    • FDA
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    Capecitabine

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    USDMF

    Found USDMF

    24689
    Active
    CAPECITABINE USP
    2011-03-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-332 - Rev 02
    Valid
    Capecitabine
    2023-02-07
    Japanese DMF

    Found JDMF

    229MF10131
    Capecitabine at Shilpa House, #12-6...
    2017-07-19
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Capecitabine (1H)
    2019-07-05
    Application Number
    24689
    R1-CEP 2014-332 - Rev 02
    229MF10131
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CAPECITABINE USP
    Capecitabine
    Capecitabine at Shilpa House, #12-6...
    Capecitabine (1H)
    Issue/Submission Date
    2011-03-24
    2023-02-07
    2017-07-19
    2019-07-05
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    • FDA
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    Gemcitabine

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    USDMF

    Found USDMF

    24136
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2011-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-222 - Rev 01
    Valid
    Gemcitabine hydrochloride
    2023-02-23
    Japanese DMF

    Found JDMF

    221MF10017
    Gemcitabine hydrochloride at 10/80,...
    2009-01-13
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Gemcitabine Hydrochloride (USP/Ph. ...
    2019-07-05
    Application Number
    24136
    R1-CEP 2006-222 - Rev 01
    221MF10017
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride
    Gemcitabine hydrochloride at 10/80,...
    Gemcitabine Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2011-03-04
    2023-02-23
    2009-01-13
    2019-07-05
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    • FDA
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    Letrozole

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    USDMF

    Found USDMF

    27489
    Active
    LETROZOLE USP
    2013-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-321 - Rev 01
    Valid
    Letrozole
    2022-07-20
    Japanese DMF

    Found JDMF

    226MF10029
    Letrozole at Shilpa House, #12-6-21...
    2014-02-05
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Letrozole (USP)
    2019-07-05
    Application Number
    27489
    R1-CEP 2013-321 - Rev 01
    226MF10029
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    LETROZOLE USP
    Letrozole
    Letrozole at Shilpa House, #12-6-21...
    Letrozole (USP)
    Issue/Submission Date
    2013-09-26
    2022-07-20
    2014-02-05
    2019-07-05
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    • FDA
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    Temozolomide

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    USDMF

    Found USDMF

    23479
    Active
    TEMOZOLOMIDE USP
    2010-01-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-277 - Rev 00
    Valid
    Temozolomide
    2022-07-12
    Japanese DMF

    Found JDMF

    228MF10125
    Temozolomide at Shilpa House, #12-6...
    2016-07-12
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Temozolomide (IH)
    2019-07-05
    Application Number
    23479
    R1-CEP 2016-277 - Rev 00
    228MF10125
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TEMOZOLOMIDE USP
    Temozolomide
    Temozolomide at Shilpa House, #12-6...
    Temozolomide (IH)
    Issue/Submission Date
    2010-01-22
    2022-07-12
    2016-07-12
    2019-07-05
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    • FDA
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-201 - Rev 05
    Valid
    Ambroxol hydrochloride
    2022-07-20
    Japanese DMF

    Found JDMF

    304MF10124
    Ambroxol Hydrochloride at Shilpa Ho...
    2022-08-24
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Ambroxol Hydrochloride (Ph. Eur.)
    2019-07-05
    Application Number
    R1-CEP 2004-201 - Rev 05
    304MF10124
    Indian CDSCO WC-0148
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Ambroxol hydrochloride
    Ambroxol Hydrochloride at Shilpa Ho...
    Ambroxol Hydrochloride (Ph. Eur.)
    Issue/Submission Date
    2022-07-20
    2022-08-24
    2019-07-05
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    • FDA
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    Azacitidine

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    USDMF

    Found USDMF

    27487
    Active
    AZACITIDINE
    2013-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10033
    Azacitidine at Shilpa House, #12-6-...
    2021-02-16
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Azacitidine IH
    2019-07-05
    Application Number
    27487
    303MF10033
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    AZACITIDINE
    Azacitidine at Shilpa House, #12-6-...
    Azacitidine IH
    Issue/Submission Date
    2013-09-23
    2021-02-16
    2019-07-05
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    • FDA
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    Bicalutamide

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    USDMF

    Found USDMF

    24690
    Active
    BICALUTAMIDE USP
    2011-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10084
    Bicalutamide at Shilpa House, #12-6...
    2013-04-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Bicalutamide (IH)
    2019-07-05
    Application Number
    24690
    225MF10084
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide at Shilpa House, #12-6...
    Bicalutamide (IH)
    Issue/Submission Date
    2011-05-11
    2013-04-23
    2019-07-05
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    • FDA
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28162
    Active
    FINGOLIMOD HYDROCHLORIDE
    2014-05-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-145 - Rev 01
    Valid
    Fingolimod hydrochloride
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Fingolimod Hydrochloride IH
    2019-07-05
    Application Number
    28162
    R0-CEP 2019-145 - Rev 01
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FINGOLIMOD HYDROCHLORIDE
    Fingolimod hydrochloride
    Fingolimod Hydrochloride IH
    Issue/Submission Date
    2014-05-30
    2022-07-21
    2019-07-05
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    • FDA
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    27927
    Active
    IMATINIB MESYLATE
    2014-03-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-121 - Rev 01
    Valid
    Imatinib mesilate
    2022-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Imatinib Mesylate(IH))
    2019-07-05
    Application Number
    27927
    R1-CEP 2016-121 - Rev 01
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    IMATINIB MESYLATE
    Imatinib mesilate
    Imatinib Mesylate(IH))
    Issue/Submission Date
    2014-03-28
    2022-07-20
    2019-07-05
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    • FDA
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    23562
    Active
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    2010-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-147 - Rev 00
    Valid
    Irinotecan hydrochloride trihydrate
    2023-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Irinotecan Hydrochloride Trihydrate...
    2019-07-05
    Application Number
    23562
    R1-CEP 2017-147 - Rev 00
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    Irinotecan hydrochloride trihydrate
    Irinotecan Hydrochloride Trihydrate...
    Issue/Submission Date
    2010-02-23
    2023-07-04
    2019-07-05
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    Oxaliplatin

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    USDMF

    Found USDMF

    23563
    Active
    OXALIPLATIN USP
    2010-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-201 - Rev 02
    Valid
    Oxaliplatin
    2022-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Oxaliplatin (Ph. Eur.)
    2019-07-05
    Application Number
    23563
    R1-CEP 2006-201 - Rev 02
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin
    Oxaliplatin (Ph. Eur.)
    Issue/Submission Date
    2010-02-23
    2022-07-20
    2019-07-05
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    Pemetrexed Disodium

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    USDMF

    Found USDMF

    25102
    Active
    PEMETREXED DISODIUM (HEMIPENTA HYDR...
    2011-09-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-087 - Rev 00
    Valid
    Pemetrexed disodium 2.5-hydrate
    2023-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Pemetrexed Disodium(IH)
    2019-07-05
    Application Number
    25102
    R0-CEP 2022-087 - Rev 00
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PEMETREXED DISODIUM (HEMIPENTA HYDR...
    Pemetrexed disodium 2.5-hydrate
    Pemetrexed Disodium(IH)
    Issue/Submission Date
    2011-09-21
    2023-07-07
    2019-07-05
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    • FDA
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    Pirfenidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30952
    Active
    PIRFENIDONE
    2016-09-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-242 - Rev 00
    Valid
    Pirfenidone
    2022-10-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Pirfenidone EP
    2019-07-05
    Application Number
    30952
    R1-CEP 2016-242 - Rev 00
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone EP
    Issue/Submission Date
    2016-09-20
    2022-10-03
    2019-07-05
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    Tranexamic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33086
    Active
    TRANEXAMIC ACID USP
    2018-09-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-048 - Rev 01
    Valid
    Tranexamic acid
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Tranexamic Acid USP/EP
    2019-07-05
    Application Number
    33086
    R0-CEP 2018-048 - Rev 01
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TRANEXAMIC ACID USP
    Tranexamic acid
    Tranexamic Acid USP/EP
    Issue/Submission Date
    2018-09-05
    2022-07-21
    2019-07-05
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    Zoledronic Acid

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    USDMF

    Found USDMF

    25905
    Active
    ZOLEDRONIC ACID
    2012-07-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-269 - Rev 00
    Valid
    Zoledronic acid monohydrate
    2023-07-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Zoledronic Acid (IH)
    2019-07-05
    Application Number
    25905
    R0-CEP 2021-269 - Rev 00
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ZOLEDRONIC ACID
    Zoledronic acid monohydrate
    Zoledronic Acid (IH)
    Issue/Submission Date
    2012-07-18
    2023-07-24
    2019-07-05
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    Anastrozole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23123
    Inactive
    ANASTROZOLE
    2009-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10034
    Anastrozole at Shilpa House, #12-6-...
    2015-02-04
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Anastrozole USP/EP
    2019-07-05
    Application Number
    23123
    227MF10034
    Indian CDSCO WC-0147
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    ANASTROZOLE
    Anastrozole at Shilpa House, #12-6-...
    Anastrozole USP/EP
    Issue/Submission Date
    2009-09-23
    2015-02-04
    2019-07-05
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    Cyclophosphamide

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    USDMF

    Found USDMF

    34066
    Active
    CYCLOPHOSPHAMIDE USP
    2019-08-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-083 - Rev 02
    Valid
    Cyclophosphamide monohydrate
    2023-01-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34066
    R0-CEP 2020-083 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CYCLOPHOSPHAMIDE USP
    Cyclophosphamide monohydrate
    Issue/Submission Date
    2019-08-08
    2023-01-09
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    Gemcitabine

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    31892
    Active
    GEMCITABINE HYDROCHLORIDE USP (PROC...
    2017-07-18
    CEP/COS

    Found CEP/COS

    CEP 2017-187 - Rev 02
    Valid
    Gemcitabine hydrochloride, Process-...
    2024-01-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31892
    CEP 2017-187 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP (PROC...
    Gemcitabine hydrochloride, Process-...
    Issue/Submission Date
    2017-07-18
    2024-01-04
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    • FDA
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    Axitinib

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30104
    Active
    AXITINIB
    2015-12-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Axitinib IH
    2021-06-11
    Application Number
    30104
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    AXITINIB
    Axitinib IH
    Issue/Submission Date
    2015-12-24
    2021-06-11
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    • FDA
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    Bendamustine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25222
    Active
    BENDAMUSTINE HCL
    2011-11-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Bendamustine HCI
    2019-07-05
    Application Number
    25222
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    BENDAMUSTINE HCL
    Bendamustine HCI
    Issue/Submission Date
    2011-11-08
    2019-07-05
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    Bortezomib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24944
    Active
    BORTEZOMIB
    2011-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Bortezomib (IH)
    2019-07-05
    Application Number
    24944
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    BORTEZOMIB
    Bortezomib (IH)
    Issue/Submission Date
    2011-08-23
    2019-07-05
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    Cabazitaxel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33087
    Active
    CABAZITAXEL
    2020-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Cabazitaxel IH
    2021-06-11
    Application Number
    33087
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    CABAZITAXEL
    Cabazitaxel IH
    Issue/Submission Date
    2020-06-30
    2021-06-11
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    Clofarabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29806
    Active
    CLOFARABINE
    2015-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Clofarabine IH
    2021-06-11
    Application Number
    29806
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    CLOFARABINE
    Clofarabine IH
    Issue/Submission Date
    2015-09-25
    2021-06-11
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    Decitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27488
    Active
    DECITABINE
    2013-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Decitabine (1H)
    2019-07-05
    Application Number
    27488
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    DECITABINE
    Decitabine (1H)
    Issue/Submission Date
    2013-09-26
    2019-07-05
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    Dimethyl Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29655
    Active
    DIMETHYL FUMARATE
    2015-09-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Dimethyl Fumarate IH
    2021-06-11
    Application Number
    29655
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    DIMETHYL FUMARATE
    Dimethyl Fumarate IH
    Issue/Submission Date
    2015-09-19
    2021-06-11
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    • FDA
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    Enzalutamide

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

    See Less

    USDMF

    Found USDMF

    30260
    Active
    ENZALUTAMIDE
    2016-03-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Enzalutamide IH
    2021-06-11
    Application Number
    30260
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ENZALUTAMIDE
    Enzalutamide IH
    Issue/Submission Date
    2016-03-17
    2021-06-11
    ASK
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    • FDA
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    Erlotinib Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    29124
    Active
    ERLOTINIB HYDROCHLORIDE (ET)
    2015-04-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Erlotinib Hydrochloride
    2019-07-05
    Application Number
    29124
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ERLOTINIB HYDROCHLORIDE (ET)
    Erlotinib Hydrochloride
    Issue/Submission Date
    2015-04-13
    2019-07-05
    ASK
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    • FDA
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    Imatinib Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28349
    Active
    IMATINIB MESYLATE (IMN)
    2014-06-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Imatinib Mesylate EP
    2021-06-11
    Application Number
    28349
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    IMATINIB MESYLATE (IMN)
    Imatinib Mesylate EP
    Issue/Submission Date
    2014-06-27
    2021-06-11
    ASK
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    • FDA
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    Lenalidomide

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

    See Less

    USDMF

    Found USDMF

    33084
    Active
    LENALIDOMIDE
    2020-04-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Lenalidomide IH
    2021-06-11
    Application Number
    33084
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    LENALIDOMIDE
    Lenalidomide IH
    Issue/Submission Date
    2020-04-04
    2021-06-11
    ASK
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    • FDA
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    Melphalan Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    28930
    Active
    MELPHALAN HYDROCHLORIDE (MPH)
    2015-01-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Melphalan HCl IH
    2021-06-11
    Application Number
    28930
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MELPHALAN HYDROCHLORIDE (MPH)
    Melphalan HCl IH
    Issue/Submission Date
    2015-01-03
    2021-06-11
    ASK
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    • FDA
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    Nifedipine

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

    See Less

    USDMF

    Found USDMF

    36235
    Active
    NIFEDIPINE-USP
    2021-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0148
    Expired
    Nifedipine (USP/Ph. Eur.)
    2019-07-05
    Application Number
    36235
    Indian CDSCO WC-0148
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    NIFEDIPINE-USP
    Nifedipine (USP/Ph. Eur.)
    Issue/Submission Date
    2021-09-11
    2019-07-05
    ASK
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    • FDA
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    Pomalidomide

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

    See Less

    USDMF

    Found USDMF

    32309
    Active
    POMALIDOMIDE
    2017-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Pomalidomide IH
    2021-06-11
    Application Number
    32309
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    POMALIDOMIDE
    Pomalidomide IH
    Issue/Submission Date
    2017-12-09
    2021-06-11
    ASK
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    • FDA
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    Praziquantel

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-207 - Rev 01
    Valid
    Praziquantel
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Praziquantel EP/USP
    2021-06-11
    Application Number
    R0-CEP 2019-207 - Rev 01
    Indian CDSCO WC-0147A3
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Praziquantel
    Praziquantel EP/USP
    Issue/Submission Date
    2022-07-21
    2021-06-11
    ASK
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    • FDA
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    Prucalopride Succinate

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

    See Less

    USDMF

    Found USDMF

    35038
    Active
    PRUCALOPRIDE SUCCINATE
    2020-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147
    Expired
    Prucalopride Succinate IH
    2019-07-05
    Application Number
    35038
    Indian CDSCO WC-0147
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    PRUCALOPRIDE SUCCINATE
    Prucalopride Succinate IH
    Issue/Submission Date
    2020-08-28
    2019-07-05
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    • FDA
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    • WHO-GMP
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    Sunitinib

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

    See Less

    USDMF

    Found USDMF

    29653
    Active
    SUNITINIB
    2021-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0147A3
    Expired
    Sunitinib Malate IH
    2021-06-11
    Application Number
    29653
    Indian CDSCO WC-0147A3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    SUNITINIB
    Sunitinib Malate IH
    Issue/Submission Date
    2021-04-21
    2021-06-11
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Anastrozole

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

    See Less

    USDMF

    Found USDMF

    29654
    Active
    ANASTROZOLE USP
    2015-09-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29654
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ANASTROZOLE USP
    Issue/Submission Date
    2015-09-18
    ASK
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    • FDA
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    Bortezomib

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

    See Less

    USDMF

    Found USDMF

    36821
    Active
    BORTEZOMIB
    2022-03-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36821
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BORTEZOMIB
    Issue/Submission Date
    2022-03-09
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Glycopyrronium Bromide

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-268 - Rev 00
    Valid
    Glycopyrronium bromide
    2023-01-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-268 - Rev 00
    Status
    Valid
     
    Filing Details
    Glycopyrronium bromide
    Issue/Submission Date
    2023-01-11
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Ibrutinib

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

    See Less

    USDMF

    Found USDMF

    32122
    Active
    IBRUTINIB
    2017-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32122
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IBRUTINIB
    Issue/Submission Date
    2017-10-04
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Irinotecan Hydrochloride

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-156 - Rev 01
    Valid
    Irinotecan hydrochloride trihydrate...
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-156 - Rev 01
    Status
    Valid
     
    Filing Details
    Irinotecan hydrochloride trihydrate...
    Issue/Submission Date
    2022-07-21
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Lenvatinib Mesylate

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

    See Less

    USDMF

    Found USDMF

    33083
    Active
    LENVATINIB MESYLATE
    2018-09-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33083
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LENVATINIB MESYLATE
    Issue/Submission Date
    2018-09-04
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Nilotinib

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

    See Less

    USDMF

    Found USDMF

    36289
    Active
    NILOTINIB
    2021-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36289
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NILOTINIB
    Issue/Submission Date
    2021-09-21
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Pemetrexed Dipotassium

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

    See Less

    USDMF

    Found USDMF

    29652
    Active
    PEMETREXED DIPOTASSIUM (NONA HYDRAT...
    2015-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29652
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PEMETREXED DIPOTASSIUM (NONA HYDRAT...
    Issue/Submission Date
    2015-09-14
    ASK
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    your Marketing & Sales content
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    • FDA
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    USDMF

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    36236
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    PHENYLEPHRINE HYDROCHLORIDE, USP
    2021-09-11
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    Application Number
    36236
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    PHENYLEPHRINE HYDROCHLORIDE, USP
    Issue/Submission Date
    2021-09-11
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    33085
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    SUNITINIB MALATE
    2018-09-19
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    Application Number
    33085
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    SUNITINIB MALATE
    Issue/Submission Date
    2018-09-19
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    33850
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    TENOFOVIR ALAFENAMIDE FUMARATE
    2019-05-17
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    Application Number
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    TENOFOVIR ALAFENAMIDE FUMARATE
    Issue/Submission Date
    2019-05-17
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    USDMF

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    32172
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    TERIFLUNOMIDE
    2017-11-04
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    Application Number
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    TERIFLUNOMIDE
    Issue/Submission Date
    2017-11-04
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    33088
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    THALIDOMIDE USP
    2018-09-02
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    Application Number
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    THALIDOMIDE USP
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    2018-09-02
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    35037
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    VARENICLINE TARTRATE
    2020-08-27
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    Application Number
    35037
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    VARENICLINE TARTRATE
    Issue/Submission Date
    2020-08-27
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