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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Natco Pharma Limited

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    Banjara Hills, Hyderabad-500 034
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    • FDA
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    Anastrozole

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    USDMF

    Found USDMF

    19687
    Active
    ANASTROZOLE
    2006-08-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-022 - Rev 00
    Valid
    Anastrozole
    2020-01-27
    Japanese DMF

    Found JDMF

    223MF10014
    Anastrozole at Natco House, Road No...
    2011-01-26
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Anastrazole EP
    2019-06-26
    Application Number
    19687
    R1-CEP 2014-022 - Rev 00
    223MF10014
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-25
    Filing Details
    ANASTROZOLE
    Anastrozole
    Anastrozole at Natco House, Road No...
    Anastrazole EP
    Issue/Submission Date
    2006-08-11
    2020-01-27
    2011-01-26
    2019-06-26
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    Gefitinib

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    USDMF

    Found USDMF

    32409
    Active
    GEFITINIB
    2018-07-24
    CEP/COS

    Found CEP/COS

    CEP 2017-244 - Rev 02
    Valid
    Gefitinib, Micronised
    2024-02-07
    Japanese DMF

    Found JDMF

    229MF10197
    GEFITINIB at Natco House, Road No. ...
    2017-11-09
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Gefitinib (IH)
    2019-06-26
    Application Number
    32409
    CEP 2017-244 - Rev 02
    229MF10197
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-25
    Filing Details
    GEFITINIB
    Gefitinib, Micronised
    GEFITINIB at Natco House, Road No. ...
    Gefitinib (IH)
    Issue/Submission Date
    2018-07-24
    2024-02-07
    2017-11-09
    2019-06-26
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    • FDA
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    20410
    Active
    IMATINIB MESYLATE (ALPHA 2-FORM)
    2007-04-05
    CEP/COS

    Found CEP/COS

    CEP 2015-273 - Rev 01
    Valid
    Imatinib mesilate
    2023-10-02
    Japanese DMF

    Found JDMF

    225MF10060
    Imatinib mesylateα2Mold at Natco H...
    2013-03-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    lmatinib Mesylate (IH/Ph. Eur.)
    2019-06-26
    Application Number
    20410
    CEP 2015-273 - Rev 01
    225MF10060
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-25
    Filing Details
    IMATINIB MESYLATE (ALPHA 2-FORM)
    Imatinib mesilate
    Imatinib mesylateα2Mold at Natco H...
    lmatinib Mesylate (IH/Ph. Eur.)
    Issue/Submission Date
    2007-04-05
    2023-10-02
    2013-03-14
    2019-06-26
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    • FDA
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    Letrozole

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    USDMF

    Found USDMF

    18388
    Active
    LETROZOLE
    2005-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-150 - Rev 03
    Valid
    Letrozole
    2017-02-14
    Japanese DMF

    Found JDMF

    226MF10005
    Letrozole at Natco House, Road No. ...
    2014-01-08
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Letrozole (USP/Ph. Eur.)
    2019-06-26
    Application Number
    18388
    R1-CEP 2007-150 - Rev 03
    226MF10005
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-25
    Filing Details
    LETROZOLE
    Letrozole
    Letrozole at Natco House, Road No. ...
    Letrozole (USP/Ph. Eur.)
    Issue/Submission Date
    2005-06-03
    2017-02-14
    2014-01-08
    2019-06-26
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    • FDA
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    Citalopram Hydrobromide

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    USDMF

    Found USDMF

    17185
    Active
    CITALOPRAM HYDROBROMIDE
    2004-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-390 - Rev 01
    Valid
    Citalopram hydrobromide
    2017-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Citalopram Hydrobromide (USP/Ph. Eu...
    2019-06-26
    Application Number
    17185
    R1-CEP 2009-390 - Rev 01
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-25
    Filing Details
    CITALOPRAM HYDROBROMIDE
    Citalopram hydrobromide
    Citalopram Hydrobromide (USP/Ph. Eu...
    Issue/Submission Date
    2004-02-04
    2017-02-14
    2019-06-26
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    19215
    Active
    GRANISETRON HYDROCHLORIDE
    2006-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10373
    Granisetron hydrochloride at Natco ...
    2007-12-19
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Granisetron Hydrochloride (USP/Ph. ...
    2019-06-26
    Application Number
    19215
    219MF10373
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-25
    Filing Details
    GRANISETRON HYDROCHLORIDE
    Granisetron hydrochloride at Natco ...
    Granisetron Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2006-03-03
    2007-12-19
    2019-06-26
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    18180
    Active
    ONDANSETRON HYDROCHLORIDE
    2005-02-25
    CEP/COS

    Found CEP/COS

    CEP 2003-221 - Rev 05
    Valid
    Ondansetron hydrochloride dihydrate
    2023-10-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Ondansetron Hydrochloride (USP)/Ond...
    2019-06-26
    Application Number
    18180
    CEP 2003-221 - Rev 05
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-25
    Filing Details
    ONDANSETRON HYDROCHLORIDE
    Ondansetron hydrochloride dihydrate
    Ondansetron Hydrochloride (USP)/Ond...
    Issue/Submission Date
    2005-02-25
    2023-10-03
    2019-06-26
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    Rizatriptan Benzoate

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    USDMF

    Found USDMF

    20781
    Active
    RIZATRIPTAN BENZOATE
    2007-08-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-268 - Rev 00
    Valid
    Rizatriptan benzoate
    2020-05-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Rizatriptan Bezoate (IH/USP/Ph. Eur...
    2019-06-26
    Application Number
    20781
    R1-CEP 2012-268 - Rev 00
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-25
    Filing Details
    RIZATRIPTAN BENZOATE
    Rizatriptan benzoate
    Rizatriptan Bezoate (IH/USP/Ph. Eur...
    Issue/Submission Date
    2007-08-21
    2020-05-15
    2019-06-26
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    Salmeterol Xinafoate

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    USDMF

    Found USDMF

    18394
    Active
    SALMETEROL XINAFOATE
    2005-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-013 - Rev 03
    Valid
    Salmeterol xinafoate
    2023-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Salmeterol Xinafoate (USP/Ph. Eur.)
    2019-06-26
    Application Number
    18394
    R1-CEP 2009-013 - Rev 03
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-25
    Filing Details
    SALMETEROL XINAFOATE
    Salmeterol xinafoate
    Salmeterol Xinafoate (USP/Ph. Eur.)
    Issue/Submission Date
    2005-06-03
    2023-04-20
    2019-06-26
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    Zoledronic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19523
    Active
    ZOLEDRONIC ACID
    2006-06-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10053
    Zoledronic acid at Natco House, Roa...
    2013-03-12
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Zoledronic Acid (IH)
    2019-06-26
    Application Number
    19523
    225MF10053
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    ZOLEDRONIC ACID
    Zoledronic acid at Natco House, Roa...
    Zoledronic Acid (IH)
    Issue/Submission Date
    2006-06-15
    2013-03-12
    2019-06-26
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    • FDA
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    Omeprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21310
    Active
    OMEPRAZOLE
    2008-02-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-148 - Rev 02
    Valid
    Omeprazole
    2017-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21310
    R1-CEP 2007-148 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Issue/Submission Date
    2008-02-05
    2017-02-14
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    Sumatriptan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16930
    Active
    SUMATRIPTAN SUCCINATE
    2003-10-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-245 - Rev 03
    Valid
    Sumatriptan succinate
    2017-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16930
    R1-CEP 2003-245 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SUMATRIPTAN SUCCINATE
    Sumatriptan succinate
    Issue/Submission Date
    2003-10-23
    2017-02-14
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    • FDA
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30845
    Active
    APIXABAN
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Apixaban IH
    2019-06-26
    Application Number
    30845
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2016-09-30
    2019-06-26
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    Bendamustine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26704
    Active
    BENDAMUSTINE HYDROCHLORIDE
    2012-12-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Bendamustine Hydrochloride (IH)
    2019-10-07
    Application Number
    26704
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE
    Bendamustine Hydrochloride (IH)
    Issue/Submission Date
    2012-12-18
    2019-10-07
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    Benzhexol hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22576
    Active
    TRIHEXYPHENIDYL HYDROCHLORIDE
    2009-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Trihexyphenidyl Hydrochloride (USP/...
    2019-06-26
    Application Number
    22576
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-25
    Filing Details
    TRIHEXYPHENIDYL HYDROCHLORIDE
    Trihexyphenidyl Hydrochloride (USP/...
    Issue/Submission Date
    2009-02-26
    2019-06-26
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    Bortezomib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26547
    Active
    BORTEZOMIB
    2012-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Bortezomib (IH)
    2019-10-07
    Application Number
    26547
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    BORTEZOMIB
    Bortezomib (IH)
    Issue/Submission Date
    2012-12-06
    2019-10-07
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    • FDA
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    Carmustine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34547
    Active
    CARMUSTINE
    2020-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Carmustine USP/Ph.Eur
    2019-10-07
    Application Number
    34547
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-12
    Filing Details
    CARMUSTINE
    Carmustine USP/Ph.Eur
    Issue/Submission Date
    2020-03-03
    2019-10-07
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    • FDA
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    Chloroquine Phosphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33067
    Active
    CHLOROQUINE PHOSPHATE
    2019-02-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Chloroquine Phosphate USP
    2019-06-26
    Application Number
    33067
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    CHLOROQUINE PHOSPHATE
    Chloroquine Phosphate USP
    Issue/Submission Date
    2019-02-20
    2019-06-26
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    Erlotinib Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21786
    Active
    ERLOTINIB HYDROCHLORIDE
    2008-07-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Erlotinib Hydrochloride (IH)
    2019-06-26
    Application Number
    21786
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    ERLOTINIB HYDROCHLORIDE
    Erlotinib Hydrochloride (IH)
    Issue/Submission Date
    2008-07-11
    2019-06-26
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    Everolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29696
    Active
    EVEROLIMUS
    2015-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Everolimus (IH)
    2019-10-07
    Application Number
    29696
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    EVEROLIMUS
    Everolimus (IH)
    Issue/Submission Date
    2015-09-30
    2019-10-07
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    Ibandronate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20411
    Active
    IBANDRONATE SODIUM MONOHYDRATE
    2007-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Ibandronate Sodium Monohydrate (IH)
    2019-06-26
    Application Number
    20411
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-25
    Filing Details
    IBANDRONATE SODIUM MONOHYDRATE
    Ibandronate Sodium Monohydrate (IH)
    Issue/Submission Date
    2007-04-05
    2019-06-26
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    Lansoprazole

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    USDMF

    Found USDMF

    23523
    Active
    LANSOPRAZOLE
    2010-02-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Lansoprazole (USP/Ph. Eur.)
    2019-06-26
    Application Number
    23523
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    LANSOPRAZOLE
    Lansoprazole (USP/Ph. Eur.)
    Issue/Submission Date
    2010-02-12
    2019-06-26
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    Lanthanum Carbonate

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    USDMF

    Found USDMF

    22050
    Active
    LANTHANUM CARBONATE DIHYDRATE
    2008-10-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Lanthanum Carbonate Dihydrate (IH)
    2019-06-26
    Application Number
    22050
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    LANTHANUM CARBONATE DIHYDRATE
    Lanthanum Carbonate Dihydrate (IH)
    Issue/Submission Date
    2008-10-02
    2019-06-26
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    Nilotinib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36308
    Active
    NILOTINIB HYDROCHLORIDE MONOHYDRATE
    2022-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014A5
    Expired
    Nilotinib Hydrochloride Monohydrate...
    2021-08-06
    Application Number
    36308
    Indian CDSCO WC-0014A5
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    NILOTINIB HYDROCHLORIDE MONOHYDRATE
    Nilotinib Hydrochloride Monohydrate...
    Issue/Submission Date
    2022-12-02
    2021-08-06
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    Pantoprazole Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    21595
    Inactive
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    2008-05-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-178 - Rev 02
    Valid
    Pantoprazole sodium sesquihydrate
    2017-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21595
    R1-CEP 2009-178 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2008-05-07
    2017-02-14
    ASK
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    Pomalidomide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31103
    Active
    POMALIDOMIDE
    2016-11-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Pomalidomide (Bulk) IH
    2019-10-07
    Application Number
    31103
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    POMALIDOMIDE
    Pomalidomide (Bulk) IH
    Issue/Submission Date
    2016-11-10
    2019-10-07
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    Sertraline Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-011 - Rev 02
    Valid
    Sertraline hydrochloride
    2017-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Sertraline Hydrochloride (IH/USP/Ph...
    2019-06-26
    Application Number
    R1-CEP 2009-011 - Rev 02
    Indian CDSCO WC-0014
    Status
    Valid
     
    Expired
    2022-06-25
    Filing Details
    Sertraline hydrochloride
    Sertraline Hydrochloride (IH/USP/Ph...
    Issue/Submission Date
    2017-02-14
    2019-06-26
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    Sugammadex Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33921
    Active
    SUGAMMADEX SODIUM
    2019-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014A4
    Expired
    Sugammadex Sodium IH
    2020-03-18
    Application Number
    33921
    Indian CDSCO WC-0014A4
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    SUGAMMADEX SODIUM
    Sugammadex Sodium IH
    Issue/Submission Date
    2019-07-08
    2020-03-18
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    Teriflunomide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30506
    Active
    TERIFLUNOMIDE
    2016-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Teriflunomide IH
    2019-06-26
    Application Number
    30506
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-25
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide IH
    Issue/Submission Date
    2016-04-29
    2019-06-26
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    Thiotepa

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31104
    Active
    THIOTEPA
    2017-05-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Thiotepa (USP/IP)
    2019-10-07
    Application Number
    31104
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    THIOTEPA
    Thiotepa (USP/IP)
    Issue/Submission Date
    2017-05-05
    2019-10-07
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    • FDA
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    Tipiracil Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33926
    Active
    TIPIRACIL HYDROCHLORIDE
    2019-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Tipiracil Hydrochloride IH
    2019-10-07
    Application Number
    33926
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    TIPIRACIL HYDROCHLORIDE
    Tipiracil Hydrochloride IH
    Issue/Submission Date
    2019-08-08
    2019-10-07
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    • FDA
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    Trifluridine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    33925
    Active
    TRIFLURIDINE
    2019-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0372
    Expired
    Trifluridine IP/USP
    2019-10-07
    Application Number
    33925
    Indian CDSCO WC-0372
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-06-12
    Filing Details
    TRIFLURIDINE
    Trifluridine IP/USP
    Issue/Submission Date
    2019-08-08
    2019-10-07
    ASK
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    • FDA
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    Zolmitriptan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21308
    Active
    ZOLMITRIPTAN
    2008-02-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Zolmitriptan (IH) ITEM(S)
    2019-06-26
    Application Number
    21308
    Indian CDSCO WC-0014
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-25
    Filing Details
    ZOLMITRIPTAN
    Zolmitriptan (IH) ITEM(S)
    Issue/Submission Date
    2008-02-05
    2019-06-26
    ASK
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    • FDA
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    Acalabrutinib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36263
    Active
    ACALABRUTINIB DIHYDRATE
    2021-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36263
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACALABRUTINIB DIHYDRATE
    Issue/Submission Date
    2021-09-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Alectinib Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36908
    Active
    ALECTINIB HYDROCHLORIDE
    2022-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36908
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ALECTINIB HYDROCHLORIDE
    Issue/Submission Date
    2022-03-25
    ASK
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    • FDA
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    Cabozantinib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36509
    Active
    CABOZANTINIB (S)-MALATE
    2022-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36509
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CABOZANTINIB (S)-MALATE
    Issue/Submission Date
    2022-02-28
    ASK
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    your Marketing & Sales content
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    • FDA
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    Eribulin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36605
    Active
    ERIBULIN MESYLATE
    2022-01-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36605
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERIBULIN MESYLATE
    Issue/Submission Date
    2022-01-06
    ASK
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    your Marketing & Sales content
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    • FDA
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    Granisetron Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    20678
    Active
    GRANISETRON HYDROCHLORIDE (INJECTAB...
    2007-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20678
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GRANISETRON HYDROCHLORIDE (INJECTAB...
    Issue/Submission Date
    2007-07-13
    ASK
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    • FDA
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    Ibandronate Sodium

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

    See Less

    USDMF

    Found USDMF

    24824
    Active
    IBANDRONATE SODIUM MONOHYDRATE (INJ...
    2011-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24824
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IBANDRONATE SODIUM MONOHYDRATE (INJ...
    Issue/Submission Date
    2011-05-31
    ASK
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    • FDA
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    Ibrutinib

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

    See Less

    USDMF

    Found USDMF

    32937
    Active
    IBRUTINIB (IBN)
    2018-08-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32937
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IBRUTINIB (IBN)
    Issue/Submission Date
    2018-08-17
    ASK
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    • FDA
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    Idelalisib

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    36371
    Active
    IDELALISIB
    2021-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36371
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IDELALISIB
    Issue/Submission Date
    2021-11-18
    ASK
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    your Marketing & Sales content
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    • FDA
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    Letrozole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22812
    Active
    LETROZOLE (LER)
    2009-05-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22812
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LETROZOLE (LER)
    Issue/Submission Date
    2009-05-29
    ASK
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    your Marketing & Sales content
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    • FDA
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    Ondansetron Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    20675
    Active
    ONDANSETRON HYDROCHLORIDE (INJECTAB...
    2007-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20675
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ONDANSETRON HYDROCHLORIDE (INJECTAB...
    Issue/Submission Date
    2007-07-12
    ASK
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    • FDA
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    Rizatriptan Benzoate

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

    See Less

    USDMF

    Found USDMF

    22763
    Active
    RIZATRIPTAN BENZOATE (ROUTE - 2; PR...
    2009-05-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22763
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIZATRIPTAN BENZOATE (ROUTE - 2; PR...
    Issue/Submission Date
    2009-05-08
    ASK
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    • FDA
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    Sorafenib

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

    See Less

    USDMF

    Found USDMF

    26693
    Active
    SORAFENIB TOSYLATE
    2012-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26693
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SORAFENIB TOSYLATE
    Issue/Submission Date
    2012-12-21
    ASK
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    • FDA
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    Sorafenib

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

    See Less

    USDMF

    Caution USDMF

    24578
    Inactive
    SORAFENIB TOSYLATE
    2011-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0014
    Expired
    Sorafenib Tosylate (IH)
    2019-06-26
    Application Number
    24578
    Indian CDSCO WC-0014
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-06-25
    Filing Details
    SORAFENIB TOSYLATE
    Sorafenib Tosylate (IH)
    Issue/Submission Date
    2011-03-10
    2019-06-26
    ASK
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    your Marketing & Sales content
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    • FDA
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    Sumatriptan

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

    See Less

    USDMF

    Found USDMF

    20894
    Active
    SUMATRIPTAN SUCCINATE (INJECTABLE G...
    2007-10-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    20894
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUMATRIPTAN SUCCINATE (INJECTABLE G...
    Issue/Submission Date
    2007-10-01
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    Sumatriptan

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    USDMF

    Caution USDMF

    19212
    Inactive
    SUMATRIPTAN
    2006-03-03
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-113 - Rev 02
    Withdrawn by Holder
    Sumatriptan succinate, STS
    2017-02-14
    Japanese DMF

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    Written Confirmation

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    Application Number
    19212
    R0-CEP 2011-113 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SUMATRIPTAN
    Sumatriptan succinate, STS
    Issue/Submission Date
    2006-03-03
    2017-02-14
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    CIDOFOVIR DIHYDRATE USP

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    USDMF

    Found USDMF

    38593
    Active
    CIDOFOVIR DIHYDRATE USP
    2023-08-23
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    38593
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CIDOFOVIR DIHYDRATE USP
    Issue/Submission Date
    2023-08-23
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    Fluoxetine Hydrochloride

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    USDMF

    Caution USDMF

    11992
    Inactive
    FLUOXETINE HYDROCHLORIDE
    1996-06-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11992
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUOXETINE HYDROCHLORIDE
    Issue/Submission Date
    1996-06-07
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