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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Cilag AG

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    Cilag AG
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    Country
    Country
    Switzerland
    Address
    Address
    Cilag AG Hochstrasse 201 8205 Schaffhausen Switzerland
    Telephone
    Telephone
     +41 (52) 630 9111
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    enquiries@pharmacompass.com
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    Cladribine

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    USDMF

    Caution USDMF

    12231
    Inactive
    CLADRIBINE
    1996-11-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-049 - Rev 00
    Valid
    Cladribine
    2021-08-20
    Japanese DMF

    Found JDMF

    305MF10067
    Cladribine at Hochstrasse201 8200 S...
    2023-05-24
    Written Confirmation

    Close WC

    Application Number
    12231
    R0-CEP 2020-049 - Rev 00
    305MF10067
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLADRIBINE
    Cladribine
    Cladribine at Hochstrasse201 8200 S...
    Issue/Submission Date
    1996-11-21
    2021-08-20
    2023-05-24
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    Remifentanil

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    USDMF

    Found USDMF

    27513
    Active
    REMIFENTANIL HCL DRUG SUBSTANCE
    2013-09-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-296 - Rev 01
    Valid
    Remifentanil hydrochloride
    2022-03-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27513
    R0-CEP 2018-296 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    REMIFENTANIL HCL DRUG SUBSTANCE
    Remifentanil hydrochloride
    Issue/Submission Date
    2013-09-06
    2022-03-22
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    Alcaftadine

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    USDMF

    Found USDMF

    20066
    Active
    ALCAFTADINE (R89674) DRUG SUBSTANCE
    2006-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20066
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALCAFTADINE (R89674) DRUG SUBSTANCE
    Issue/Submission Date
    2006-12-21
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    Cladribine

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    USDMF

    Found USDMF

    17603
    Active
    CLADRIBINE DRUG SUBSTANCE
    2004-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17603
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CLADRIBINE DRUG SUBSTANCE
    Issue/Submission Date
    2004-08-16
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    Iron Sucrose

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    USDMF

    Found USDMF

    19544
    Active
    IRON SUCROSE DRUG SUBSTANCE
    2006-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19544
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IRON SUCROSE DRUG SUBSTANCE
    Issue/Submission Date
    2006-06-26
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    Mefloquine

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    USDMF

    Found USDMF

    15413
    Active
    MEFLOQUINE HYDROCHLORIDE
    2001-05-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15413
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MEFLOQUINE HYDROCHLORIDE
    Issue/Submission Date
    2001-05-04
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    2-Benzylaminopyridine

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    USDMF

    Caution USDMF

    8809
    Inactive
    2-BENZYLAMINO-PYRIDINE
    1990-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8809
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    2-BENZYLAMINO-PYRIDINE
    Issue/Submission Date
    1990-10-31
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    Acetrizoic Acid

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    USDMF

    Caution USDMF

    3166
    Inactive
    ACETRIZOIC ACID
    1978-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3166
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ACETRIZOIC ACID
    Issue/Submission Date
    1978-02-08
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    Amantadine Hydrochloride

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    USDMF

    Caution USDMF

    2817
    Inactive
    AMANTADINE HCL
    1977-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2817
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AMANTADINE HCL
    Issue/Submission Date
    1977-01-07
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    Bepridil

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    USDMF

    Caution USDMF

    4859
    Inactive
    BEPRIDIL HCL
    1983-04-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4859
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BEPRIDIL HCL
    Issue/Submission Date
    1983-04-08
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    Bupropion Hydrochloride

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    USDMF

    Caution USDMF

    12089
    Inactive
    BUPROPION HYDROCHLORIDE
    1996-08-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12089
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BUPROPION HYDROCHLORIDE
    Issue/Submission Date
    1996-08-12
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    Chlorzoxazone

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    USDMF

    Caution USDMF

    4956
    Inactive
    CHLORZOXAZONE
    1983-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4956
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CHLORZOXAZONE
    Issue/Submission Date
    1983-04-11
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    Cyclobenzaprine

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    USDMF

    Caution USDMF

    8101
    Inactive
    CYCLOBENZAPRINE HCL
    1989-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8101
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CYCLOBENZAPRINE HCL
    Issue/Submission Date
    1989-06-08
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    Divalproex Sodium

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    USDMF

    Caution USDMF

    16224
    Inactive
    DIVALPROEX SODIUM
    2002-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16224
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DIVALPROEX SODIUM
    Issue/Submission Date
    2002-11-05
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    Doxazosin Mesylate

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    USDMF

    Caution USDMF

    14173
    Inactive
    DOXAZOSIN MESYLATE
    1999-06-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14173
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DOXAZOSIN MESYLATE
    Issue/Submission Date
    1999-06-03
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    Econazole Nitrate

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    USDMF

    Caution USDMF

    2877
    Inactive
    ECONAZOLE NITRATE
    1977-03-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2877
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ECONAZOLE NITRATE
    Issue/Submission Date
    1977-03-02
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    Eudragit E

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    USDMF

    Caution USDMF

    3170
    Inactive
    EUDRAGITr E
    1978-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3170
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    EUDRAGITr E
    Issue/Submission Date
    1978-02-08
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    Fluoxetine Hydrochloride

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    USDMF

    Caution USDMF

    12221
    Inactive
    FLUOXETINE HYDROCHORIDE
    1996-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12221
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FLUOXETINE HYDROCHORIDE
    Issue/Submission Date
    1996-11-15
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    Fosphenytoin Sodium

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    USDMF

    Caution USDMF

    18954
    Inactive
    FOSPHENYTOIN SODIUM DRUG SUBSTANCE ...
    2005-11-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18954
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FOSPHENYTOIN SODIUM DRUG SUBSTANCE ...
    Issue/Submission Date
    2005-11-14
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    Guanabenz

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    7957
    Inactive
    GUANABENZ ACETATE
    1989-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7957
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GUANABENZ ACETATE
    Issue/Submission Date
    1989-03-07
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    Isoproterenol Hydrochloride

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    USDMF

    Caution USDMF

    1227
    Inactive
    MANUF FACILS AND CONTROLS FOR ISOPR...
    1968-09-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1227
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUF FACILS AND CONTROLS FOR ISOPR...
    Issue/Submission Date
    1968-09-03
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    Ketorolac Trometamol

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    USDMF

    Caution USDMF

    11799
    Inactive
    KETOROLAC TROMETHAMINE
    1996-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11799
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    KETOROLAC TROMETHAMINE
    Issue/Submission Date
    1996-01-04
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    Mesalazine

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    USDMF

    Caution USDMF

    6605
    Inactive
    MESALAZINE
    1986-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6605
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MESALAZINE
    Issue/Submission Date
    1986-09-23
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    Methimazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    3619
    Inactive
    NDC 12502 - 1819 METHIMAZOLE
    1979-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3619
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    NDC 12502 - 1819 METHIMAZOLE
    Issue/Submission Date
    1979-08-29
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    Molindone

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    USDMF

    Caution USDMF

    7992
    Inactive
    MOLINDONE HYDROCHLORIDE
    1989-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7992
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MOLINDONE HYDROCHLORIDE
    Issue/Submission Date
    1989-03-21
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    Oxaprozin

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    USDMF

    Caution USDMF

    11867
    Inactive
    OXAPROZIN
    1996-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11867
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXAPROZIN
    Issue/Submission Date
    1996-02-28
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    Phenazopyridine

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    USDMF

    Caution USDMF

    3630
    Inactive
    PRODUCT NDC 12502 - 1848 PHENAZOPYR...
    1979-10-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3630
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PRODUCT NDC 12502 - 1848 PHENAZOPYR...
    Issue/Submission Date
    1979-10-03
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    Pyridostigmine

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    USDMF

    Caution USDMF

    9029
    Inactive
    PYRIDOSTIGMINE BROMIDE
    1991-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9029
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PYRIDOSTIGMINE BROMIDE
    Issue/Submission Date
    1991-03-25
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    Rimantadine Hydrochloride

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    USDMF

    Caution USDMF

    10233
    Inactive
    RIMANTADINE HYDROCHLORIDE
    1993-05-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10233
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RIMANTADINE HYDROCHLORIDE
    Issue/Submission Date
    1993-05-05
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    Sodium ferric gluconate

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    USDMF

    Caution USDMF

    17602
    Inactive
    SODIUM FERRIC GLUCONATE
    2004-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17602
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SODIUM FERRIC GLUCONATE
    Issue/Submission Date
    2004-08-13
    ASK
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    Sodium Zomepirac

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    USDMF

    Caution USDMF

    4179
    Inactive
    ZOMEPIRAC SODIUM DIHYDRATE
    1981-05-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4179
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ZOMEPIRAC SODIUM DIHYDRATE
    Issue/Submission Date
    1981-05-01
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    Succimer

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    USDMF

    Caution USDMF

    7947
    Inactive
    SUCCIMER
    1989-02-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7947
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SUCCIMER
    Issue/Submission Date
    1989-02-24
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    Sulfiram

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    USDMF

    Caution USDMF

    5754
    Inactive
    DISULFIRAM
    1985-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5754
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DISULFIRAM
    Issue/Submission Date
    1985-03-20
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    Suprofen

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    USDMF

    Caution USDMF

    4576
    Inactive
    SUPROFEN
    1982-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4576
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SUPROFEN
    Issue/Submission Date
    1982-04-21
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    Terazosin HCl

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    USDMF

    Caution USDMF

    12649
    Inactive
    TERAZOSIN HYDROCHLORIDE MONOHYDRATE
    1997-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12649
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERAZOSIN HYDROCHLORIDE MONOHYDRATE
    Issue/Submission Date
    1997-09-08
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    Terfenadine

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    USDMF

    Caution USDMF

    8398
    Inactive
    TERFENADINE
    1990-01-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8398
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERFENADINE
    Issue/Submission Date
    1990-01-25
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    Tolmetin Sodium

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    USDMF

    Caution USDMF

    2537
    Inactive
    TOLMETIN SODIUM DIHYDRATE
    1975-10-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2537
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TOLMETIN SODIUM DIHYDRATE
    Issue/Submission Date
    1975-10-21
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    Topiramate

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    USDMF

    Caution USDMF

    10978
    Inactive
    TOPIRAMATE
    1994-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10978
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TOPIRAMATE
    Issue/Submission Date
    1994-07-08
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    Tramadol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2006-262 - Rev 00
    Withdrawn by Holder
    Tramadol hydrochloride
    2008-11-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2006-262 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Tramadol hydrochloride
    Issue/Submission Date
    2008-11-07
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    Tretinoin

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    USDMF

    Caution USDMF

    11580
    Inactive
    RETINAMIDIC ACID
    1995-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11580
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    RETINAMIDIC ACID
    Issue/Submission Date
    1995-07-13
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    Warfarin Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-005 - Rev 04
    Withdrawn by Holder
    Warfarin sodium, amorphous; amorpho...
    2010-06-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1997-005 - Rev 04
    Status
    Withdrawn by Holder
     
    Filing Details
    Warfarin sodium, amorphous; amorpho...
    Issue/Submission Date
    2010-06-30
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    3-AMINOOPROPIONITRILE FUMARATE

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    USDMF

    Caution USDMF

    1127
    Inactive
    3-AMINOOPROPIONITRILE FUMARATE
    1968-01-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1127
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    3-AMINOOPROPIONITRILE FUMARATE
    Issue/Submission Date
    1968-01-15
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    PRODUCTION & CONTROL (HOLDER NAME CHANGED 4.9.81 TO CI...

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    USDMF

    Caution USDMF

    2670
    Inactive
    PRODUCTION & CONTROL (HOLDER NAME ...
    1976-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2670
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PRODUCTION & CONTROL (HOLDER NAME ...
    Issue/Submission Date
    1976-04-29
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    FACIL.,PERS.,GEN OP PROC.;MNFG SOLID,SEMI-SOLID,&LIQUID...

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    USDMF

    Caution USDMF

    4674
    Inactive
    FACIL.,PERS.,GEN OP PROC.;MNFG SOLI...
    1982-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4674
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACIL.,PERS.,GEN OP PROC.;MNFG SOLI...
    Issue/Submission Date
    1982-09-30
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    THYMOPENTIN ACETATE HYDRATE

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    USDMF

    Caution USDMF

    6314
    Inactive
    THYMOPENTIN ACETATE HYDRATE
    1986-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6314
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    THYMOPENTIN ACETATE HYDRATE
    Issue/Submission Date
    1986-03-03
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    IRI -695

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    USDMF

    Caution USDMF

    11183
    Inactive
    IRI -695
    1994-11-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11183
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IRI -695
    Issue/Submission Date
    1994-11-08
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