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    Laurus Labs
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    India
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    2nd Floor, Serene Chambers, Rd # 7,Banjara Hills, Hyderabad 500 034
    Telephone
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    +91 40 3980 4333
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    enquiries@pharmacompass.com
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    https://www.lauruslabs.com/
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    Gemcitabine

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    USDMF

    Found USDMF

    22800
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2009-05-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-026 - Rev 02
    Valid
    Gemcitabine hydrochloride
    2023-01-24
    Japanese DMF

    Found JDMF

    230MF10069
    Gemcitabine Hydrochloride at 2nd Fl...
    2018-06-05
    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Gemcitabine Hydrchloride (USP/BP/IH...
    2023-07-03
    Application Number
    22800
    R1-CEP 2009-026 - Rev 02
    230MF10069
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride
    Gemcitabine Hydrochloride at 2nd Fl...
    Gemcitabine Hydrchloride (USP/BP/IH...
    Issue/Submission Date
    2009-05-16
    2023-01-24
    2018-06-05
    2023-07-03
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    Abacavir Sulfate

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    USDMF

    Found USDMF

    28818
    Active
    ABACAVIR SULFATE, USP
    2014-12-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-353 - Rev 01
    Valid
    Abacavir sulfate
    2023-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Abacavir Sulfate (USP/IH/Ph. Eur/Ph...
    2023-07-03
    Application Number
    28818
    R1-CEP 2014-353 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    ABACAVIR SULFATE, USP
    Abacavir sulfate
    Abacavir Sulfate (USP/IH/Ph. Eur/Ph...
    Issue/Submission Date
    2014-12-15
    2023-02-15
    2023-07-03
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    Bortezomib

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    USDMF

    Found USDMF

    26774
    Active
    BORTEZOMIB
    2012-12-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10207
    Bortezomib Hydrate at 2nd Floor, Se...
    2016-11-02
    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Bortezomib (IH)
    2023-07-03
    Application Number
    26774
    228MF10207
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    BORTEZOMIB
    Bortezomib Hydrate at 2nd Floor, Se...
    Bortezomib (IH)
    Issue/Submission Date
    2012-12-19
    2016-11-02
    2023-07-03
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    Docetaxel

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    USDMF

    Found USDMF

    23138
    Active
    DOCETAXEL ANHYDROUS USP
    2009-09-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-287 - Rev 01
    Valid
    Docetaxel, Process-2
    2023-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    docetaxel anhydrous IP/IH/EP
    2023-07-03
    Application Number
    23138
    R1-CEP 2012-287 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DOCETAXEL ANHYDROUS USP
    Docetaxel, Process-2
    docetaxel anhydrous IP/IH/EP
    Issue/Submission Date
    2009-09-24
    2023-01-20
    2023-07-03
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    Hydroxychloroquine Sulphate

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    USDMF

    Found USDMF

    31956
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    2017-09-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-129 - Rev 02
    Valid
    Hydroxychloroquine sulfate
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Hydroxychloroquine Sulphate USP
    2023-07-03
    Application Number
    31956
    R0-CEP 2020-129 - Rev 02
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Hydroxychloroquine sulfate
    Hydroxychloroquine Sulphate USP
    Issue/Submission Date
    2017-09-08
    2023-01-25
    2023-07-03
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    27089
    Active
    IMATINIB MESYLATE
    2013-05-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-245 - Rev 01
    Valid
    Imatinib mesilate
    2023-01-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Imatinib Mesylate (IH)
    2023-07-03
    Application Number
    27089
    R1-CEP 2015-245 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    IMATINIB MESYLATE
    Imatinib mesilate
    Imatinib Mesylate (IH)
    Issue/Submission Date
    2013-05-09
    2023-01-18
    2023-07-03
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    22296
    Active
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    2008-11-21
    CEP/COS

    Found CEP/COS

    CEP 2019-292 - Rev 02
    Valid
    Irinotecan hydrochloride trihydrate
    2023-12-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Irinotecan Hydrochloride Trihydrate...
    2023-07-03
    Application Number
    22296
    CEP 2019-292 - Rev 02
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE...
    Irinotecan hydrochloride trihydrate
    Irinotecan Hydrochloride Trihydrate...
    Issue/Submission Date
    2008-11-21
    2023-12-11
    2023-07-03
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    Lamivudine

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    USDMF

    Found USDMF

    31854
    Active
    LAMIVUDINE USP
    2017-07-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-045 - Rev 01
    Valid
    Lamivudine
    2023-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Lamivudine (USP/BP/Ph. Eur/Ph.Int)
    2023-07-03
    Application Number
    31854
    R1-CEP 2016-045 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LAMIVUDINE USP
    Lamivudine
    Lamivudine (USP/BP/Ph. Eur/Ph.Int)
    Issue/Submission Date
    2017-07-07
    2023-01-24
    2023-07-03
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    Metformin

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    USDMF

    Found USDMF

    30114
    Active
    METFORMIN HYDROCHLORIDE USP
    2016-05-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-319 - Rev 01
    Valid
    Metformin Hydrochloride
    2023-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Metformin Hydrochloride (IP/USP/Ph....
    2023-07-03
    Application Number
    30114
    R1-CEP 2016-319 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    METFORMIN HYDROCHLORIDE USP
    Metformin Hydrochloride
    Metformin Hydrochloride (IP/USP/Ph....
    Issue/Submission Date
    2016-05-04
    2023-01-24
    2023-07-03
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    Montelukast Sodium

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    USDMF

    Found USDMF

    23736
    Active
    MONTELUKAST SODIUM USP
    2010-04-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-311 - Rev 01
    Valid
    Montelukast sodium, Alternate proce...
    2023-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Montelukast Sodium (USP/IH/Ph. Eur....
    2023-07-03
    Application Number
    23736
    R1-CEP 2013-311 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MONTELUKAST SODIUM USP
    Montelukast sodium, Alternate proce...
    Montelukast Sodium (USP/IH/Ph. Eur....
    Issue/Submission Date
    2010-04-16
    2023-01-24
    2023-07-03
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    Oseltamivir Phosphate

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    USDMF

    Found USDMF

    33767
    Active
    OSELTAMIVIR PHOSPHATE USP
    2020-01-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-122 - Rev 01
    Valid
    Oseltamivir phosphate
    2023-05-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Oseltamivir Phosphate In house
    2023-07-03
    Application Number
    33767
    R0-CEP 2020-122 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    OSELTAMIVIR PHOSPHATE USP
    Oseltamivir phosphate
    Oseltamivir Phosphate In house
    Issue/Submission Date
    2020-01-10
    2023-05-25
    2023-07-03
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    Pregabalin

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    USDMF

    Found USDMF

    31415
    Active
    PREGABALIN
    2017-05-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-266 - Rev 02
    Valid
    Pregabalin
    2023-02-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Pregabalin Inhouse/Ph.Eur
    2023-07-03
    Application Number
    31415
    R0-CEP 2017-266 - Rev 02
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    PREGABALIN
    Pregabalin
    Pregabalin Inhouse/Ph.Eur
    Issue/Submission Date
    2017-05-06
    2023-02-23
    2023-07-03
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    Ritonavir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33342
    Active
    RITONAVIR USP
    2019-08-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-102 - Rev 01
    Valid
    Ritonavir
    2023-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Ritonavir In house/Ph.Eur
    2023-07-03
    Application Number
    33342
    R0-CEP 2020-102 - Rev 01
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    RITONAVIR USP
    Ritonavir
    Ritonavir In house/Ph.Eur
    Issue/Submission Date
    2019-08-30
    2023-03-28
    2023-07-03
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    Carboplatin

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    USDMF

    Found USDMF

    21918
    Active
    CARBOPLATIN USP DRUG SUBSTANCE
    2008-08-29
    CEP/COS

    Found CEP/COS

    CEP 2010-348 - Rev 04
    Valid
    Carboplatin
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0177
    Expired
    Carboplatin (USP/Ph. Eur./BP)
    2019-08-16
    Application Number
    21918
    CEP 2010-348 - Rev 04
    Indian CDSCO WC-0177
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    CARBOPLATIN USP DRUG SUBSTANCE
    Carboplatin
    Carboplatin (USP/Ph. Eur./BP)
    Issue/Submission Date
    2008-08-29
    2024-03-25
    2019-08-16
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    Cisplatin

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    USDMF

    Found USDMF

    21917
    Active
    CISPLATIN USP DRUG SUBSTANCE
    2008-08-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-015 - Rev 02
    Valid
    Cisplatin
    2023-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0177
    Expired
    Cisplatin (USP/Ph. Eur./BP/JP)
    2019-08-16
    Application Number
    21917
    R1-CEP 2012-015 - Rev 02
    Indian CDSCO WC-0177
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-08-15
    Filing Details
    CISPLATIN USP DRUG SUBSTANCE
    Cisplatin
    Cisplatin (USP/Ph. Eur./BP/JP)
    Issue/Submission Date
    2008-08-29
    2023-01-19
    2019-08-16
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    Lamivudine

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    USDMF

    Found USDMF

    32633
    Active
    LAMIVUDINE USP (PROCESS 1)
    2018-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-133 - Rev 02
    Valid
    Lamivudine, Process 1
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0395
    Expired
    Lamivudine EP/BP/IP/USP/IH
    2019-01-28
    Application Number
    32633
    R0-CEP 2019-133 - Rev 02
    Indian CDSCO WC-0395
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2020-03-22
    Filing Details
    LAMIVUDINE USP (PROCESS 1)
    Lamivudine, Process 1
    Lamivudine EP/BP/IP/USP/IH
    Issue/Submission Date
    2018-03-31
    2023-01-25
    2019-01-28
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    Lopinavir

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    USDMF

    Found USDMF

    33919
    Active
    LOPINAVIR USP
    2019-06-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-103 - Rev 01
    Valid
    Lopinavir
    2023-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0459A2
    Expired
    Lopinavir USP/EP/IP
    2021-03-25
    Application Number
    33919
    R0-CEP 2020-103 - Rev 01
    Indian CDSCO WC-0459A2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-11-27
    Filing Details
    LOPINAVIR USP
    Lopinavir
    Lopinavir USP/EP/IP
    Issue/Submission Date
    2019-06-25
    2023-01-25
    2021-03-25
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    Oxaliplatin

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    USDMF

    Found USDMF

    22387
    Active
    OXALIPLATIN USP
    2008-12-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-357 - Rev 03
    Valid
    Oxaliplatin, Process 2
    2023-01-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0177
    Expired
    Oxaliplatin (USP/Ph. Eur.)
    2019-08-16
    Application Number
    22387
    R1-CEP 2011-357 - Rev 03
    Indian CDSCO WC-0177
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-15
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin, Process 2
    Oxaliplatin (USP/Ph. Eur.)
    Issue/Submission Date
    2008-12-22
    2023-01-19
    2019-08-16
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    Pirfenidone

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    URL Supplier Web Content
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    USDMF

    Found USDMF

    32739
    Active
    PIRFENIDONE
    2018-05-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-062 - Rev 01
    Valid
    Pirfenidone
    2023-04-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0395A1
    Expired
    Pirfenidone (EP/IHS)
    2019-03-05
    Application Number
    32739
    R0-CEP 2019-062 - Rev 01
    Indian CDSCO WC-0395A1
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2020-03-22
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone (EP/IHS)
    Issue/Submission Date
    2018-05-04
    2023-04-11
    2019-03-05
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    Atazanavir Sulfate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30934
    Active
    ATAZANAVIR SULFATE
    2016-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Atazanavir Sulphate (IH)
    2023-07-03
    Application Number
    30934
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ATAZANAVIR SULFATE
    Atazanavir Sulphate (IH)
    Issue/Submission Date
    2016-09-29
    2023-07-03
    ASK
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    Atorvastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    32214
    Active
    ATORVASTATIN CALCIUM TRIHYDRATE USP
    2018-07-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-150 - Rev 01
    Valid
    Atorvastatin calcium
    2023-03-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32214
    R0-CEP 2021-150 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATORVASTATIN CALCIUM TRIHYDRATE USP
    Atorvastatin calcium
    Issue/Submission Date
    2018-07-18
    2023-03-28
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    Azacitidine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26846
    Active
    AZACITIDINE
    2013-02-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Azacitidine (IH)
    2023-07-03
    Application Number
    26846
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    AZACITIDINE
    Azacitidine (IH)
    Issue/Submission Date
    2013-02-07
    2023-07-03
    ASK
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    Bictegravir Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36444
    Active
    BICTEGRAVIR SODIUM
    2021-12-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Bictegravir Sodium IH
    2023-07-03
    Application Number
    36444
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    BICTEGRAVIR SODIUM
    Bictegravir Sodium IH
    Issue/Submission Date
    2021-12-24
    2023-07-03
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    Cabazitaxel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28293
    Active
    CABAZITAXEL
    2014-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Cabazitaxel IH
    2023-07-03
    Application Number
    28293
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CABAZITAXEL
    Cabazitaxel IH
    Issue/Submission Date
    2014-06-12
    2023-07-03
    ASK
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    • FDA
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    Canagliflozin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31233
    Active
    CANAGLIFLOZIN
    2017-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Canagliflozin IH
    2023-07-03
    Application Number
    31233
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CANAGLIFLOZIN
    Canagliflozin IH
    Issue/Submission Date
    2017-01-22
    2023-07-03
    ASK
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    Carfilzomib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30115
    Active
    CARFILZOMIB
    2016-03-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Carflizomib (IH)
    2023-07-03
    Application Number
    30115
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    CARFILZOMIB
    Carflizomib (IH)
    Issue/Submission Date
    2016-03-22
    2023-07-03
    ASK
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    Darunavir

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    31198
    Active
    DARUNAVIR
    2017-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Darunavir (IH)
    2023-07-03
    Application Number
    31198
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    DARUNAVIR
    Darunavir (IH)
    Issue/Submission Date
    2017-10-24
    2023-07-03
    ASK
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    Dolutegravir Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30935
    Active
    DOLUTEGRAVIR SODIUM
    2016-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Dolutegravir Sodium IH
    2023-07-03
    Application Number
    30935
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    DOLUTEGRAVIR SODIUM
    Dolutegravir Sodium IH
    Issue/Submission Date
    2016-09-28
    2023-07-03
    ASK
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    Efavirenz

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21964
    Active
    EFAVIRENZ USP
    2008-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Efavirenz (USP/IH/Ph.Int)
    2023-07-03
    Application Number
    21964
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    EFAVIRENZ USP
    Efavirenz (USP/IH/Ph.Int)
    Issue/Submission Date
    2008-09-10
    2023-07-03
    ASK
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    Emtricitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23773
    Active
    EMTRICITABINE
    2010-04-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Emtricitabine (IH/ Ph.lnt)
    2023-07-03
    Application Number
    23773
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    EMTRICITABINE
    Emtricitabine (IH/ Ph.lnt)
    Issue/Submission Date
    2010-04-28
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Enzalutamide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31196
    Active
    ENZALUTAMIDE
    2016-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Enzalutamide IH
    2023-07-03
    Application Number
    31196
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ENZALUTAMIDE
    Enzalutamide IH
    Issue/Submission Date
    2016-12-30
    2023-07-03
    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

    34313
    Active
    ERLOTINIB HYDROCHLORIDE
    2020-01-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Erlotinib Hydrochloride (IH)
    2023-07-03
    Application Number
    34313
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    ERLOTINIB HYDROCHLORIDE
    Erlotinib Hydrochloride (IH)
    Issue/Submission Date
    2020-01-08
    2023-07-03
    ASK
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    your Marketing & Sales content
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    Fluocytosine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    37631
    Active
    5-FLUOROCYTOSINE (FLUCYTOSINE) USP
    2022-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    5-Fluorocytosine USP
    2023-07-03
    Application Number
    37631
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    5-FLUOROCYTOSINE (FLUCYTOSINE) USP
    5-Fluorocytosine USP
    Issue/Submission Date
    2022-11-30
    2023-07-03
    ASK
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    Imatinib Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    33312
    Active
    IMATINIB MESYLATE (PROCESS-2)
    2018-11-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-086 - Rev 01
    Valid
    Imatinib mesilate, Process II
    2023-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33312
    R0-CEP 2020-086 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IMATINIB MESYLATE (PROCESS-2)
    Imatinib mesilate, Process II
    Issue/Submission Date
    2018-11-16
    2023-02-03
    ASK
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    • FDA
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    Pazopanib Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    36689
    Active
    PAZOPANIB HYDROCHLORIDE
    2022-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Pazopanib Hydrochloride In house
    2023-07-03
    Application Number
    36689
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PAZOPANIB HYDROCHLORIDE
    Pazopanib Hydrochloride In house
    Issue/Submission Date
    2022-02-28
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Pemetrexed Disodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    26431
    Active
    PEMETREXED DISODIUM
    2012-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Pemetrexed Disodium USP/ln house/l....
    2023-07-03
    Application Number
    26431
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    PEMETREXED DISODIUM
    Pemetrexed Disodium USP/ln house/l....
    Issue/Submission Date
    2012-09-11
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Rilpivirine Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    29841
    Active
    RILPIVIRINE HYDROCHLORIDE
    2015-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Rilpivirine HCl IH
    2023-07-03
    Application Number
    29841
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    RILPIVIRINE HYDROCHLORIDE
    Rilpivirine HCl IH
    Issue/Submission Date
    2015-12-08
    2023-07-03
    ASK
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    • FDA
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    Sitagliptin Phosphate

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

    See Less

    USDMF

    Found USDMF

    35584
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    2021-03-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-215 - Rev 01
    Valid
    Sitagliptin phosphate monohydrate
    2023-03-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35584
    R0-CEP 2020-215 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2021-03-16
    2023-03-10
    ASK
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    your Marketing & Sales content
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    • FDA
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    Sofosbuvir

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

    See Less

    USDMF

    Found USDMF

    32068
    Active
    SOFOSBUVIR
    2017-11-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Sofosbuvir (IH)
    2023-07-03
    Application Number
    32068
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    SOFOSBUVIR
    Sofosbuvir (IH)
    Issue/Submission Date
    2017-11-10
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Tenofovir Alafenamide Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    33541
    Active
    TENOFOVIR ALAFENAMIDE FUMARATE
    2019-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Tenofovir Alafenamide Fumarate In H...
    2023-07-03
    Application Number
    33541
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    TENOFOVIR ALAFENAMIDE FUMARATE
    Tenofovir Alafenamide Fumarate In H...
    Issue/Submission Date
    2019-02-28
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Thalidomide

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

    See Less

    USDMF

    Found USDMF

    27967
    Active
    THALIDOMIDE USP
    2014-03-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Thalidomide (USP/IH)
    2023-07-03
    Application Number
    27967
    Indian CDSCO WC-0213
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    THALIDOMIDE USP
    Thalidomide (USP/IH)
    Issue/Submission Date
    2014-03-05
    2023-07-03
    ASK
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    your Marketing & Sales content
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    • FDA
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    Empagliflozin

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

    See Less

    USDMF

    Found USDMF

    32881
    Active
    EMPAGLIFLOZIN
    2018-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0395A2
    Expired
    Empagliflozin IH
    2020-05-12
    Application Number
    32881
    Indian CDSCO WC-0395A2
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2023-03-22
    Filing Details
    EMPAGLIFLOZIN
    Empagliflozin IH
    Issue/Submission Date
    2018-06-26
    2020-05-12
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    Gemcitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2015-054 - Rev 00
    Expired
    Gemcitabine hydrochloride, Process-...
    2015-07-31
    Japanese DMF

    Found JDMF

    224MF10027
    Gemcitabine hydrochloride at 2nd Fl...
    2012-02-07
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2015-054 - Rev 00
    224MF10027
    Status
    Expired
     
    Filing Details
    Gemcitabine hydrochloride, Process-...
    Gemcitabine hydrochloride at 2nd Fl...
    Issue/Submission Date
    2015-07-31
    2012-02-07
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    Macitentan

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    USDMF

    Found USDMF

    31957
    Active
    MACITENTAN
    2017-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0177
    Expired
    Macitentan IH
    2019-08-16
    Application Number
    31957
    Indian CDSCO WC-0177
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    MACITENTAN
    Macitentan IH
    Issue/Submission Date
    2017-09-15
    2019-08-16
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    Tenofovir Disoproxil Fumarate

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    USDMF

    Caution USDMF

    23450
    Inactive
    TENOFOVIR DISOPROXIL FUMARATE
    2010-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0213
    Valid
    Tenofovir Disoproxil Phosphate (IH)
    2023-07-03
    Application Number
    23450
    Indian CDSCO WC-0213
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-02
    Filing Details
    TENOFOVIR DISOPROXIL FUMARATE
    Tenofovir Disoproxil Phosphate (IH)
    Issue/Submission Date
    2010-01-07
    2023-07-03
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    Valsartan

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    USDMF

    Found USDMF

    38450
    Active
    VALSARTAN USP
    2023-08-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0395A4
    Expired
    Valsartan IH/EP
    2020-12-04
    Application Number
    38450
    Indian CDSCO WC-0395A4
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2023-03-22
    Filing Details
    VALSARTAN USP
    Valsartan IH/EP
    Issue/Submission Date
    2023-08-18
    2020-12-04
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    Docetaxel

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    USDMF

    Found USDMF

    26595
    Active
    DOCETAXEL ANHYDROUS, USP (PROCESS-2...
    2012-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26595
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOCETAXEL ANHYDROUS, USP (PROCESS-2...
    Issue/Submission Date
    2012-10-30
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    Dolutegravir Sodium

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    USDMF

    Found USDMF

    31855
    Active
    DOLUTEGRAVIR SODIUM (PROCESS-2)
    2017-07-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31855
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOLUTEGRAVIR SODIUM (PROCESS-2)
    Issue/Submission Date
    2017-07-05
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    Efavirenz

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    USDMF

    Found USDMF

    26242
    Active
    EFAVIRENZ USP (PROCESS-2)
    2012-07-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26242
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EFAVIRENZ USP (PROCESS-2)
    Issue/Submission Date
    2012-07-17
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    Tenofovir Disoproxil Fumarate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    27087
    Active
    TENOFOVIR DISOPROXIL FUMARATE (PROC...
    2013-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27087
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TENOFOVIR DISOPROXIL FUMARATE (PROC...
    Issue/Submission Date
    2013-05-09
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