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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Cambrex Corporation

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    Cambrex Corporation
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    Country
    U.S.A
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    Address
    One Meadowlands Plaza, East Rutherford, NJ 07073
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    Telephone
    +1 201-804-3000
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.cambrex.com/
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    • FDA
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    Amiodarone Hydrochloride

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    USDMF

    Found USDMF

    3505
    Active
    AMIODARONE HCL
    1979-04-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-127 - Rev 02
    Valid
    Amiodarone hydrochloride
    2017-04-04
    Japanese DMF

    Found JDMF

    218MF10853
    Hydrochloric acid amiodarone at Via...
    2006-10-20
    Written Confirmation

    Close WC

    Application Number
    3505
    R1-CEP 2005-127 - Rev 02
    218MF10853
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMIODARONE HCL
    Amiodarone hydrochloride
    Hydrochloric acid amiodarone at Via...
    Issue/Submission Date
    1979-04-11
    2017-04-04
    2006-10-20
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    Bupivacaine Hydrochloride

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    USDMF

    Found USDMF

    5984
    Active
    BUPIVACAINE HYDROCHLORIDE
    1985-08-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-254 - Rev 00
    Valid
    Bupivacaine hydrochloride
    2019-01-31
    Japanese DMF

    Found JDMF

    218MF10875
    Bupivacaine hydrochloride at SE-691...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    5984
    R1-CEP 2011-254 - Rev 00
    218MF10875
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUPIVACAINE HYDROCHLORIDE
    Bupivacaine hydrochloride
    Bupivacaine hydrochloride at SE-691...
    Issue/Submission Date
    1985-08-27
    2019-01-31
    2006-11-10
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    Epinephrine

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    USDMF

    Found USDMF

    25989
    Active
    EPINEPHRINE
    2012-04-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-266 - Rev 01
    Valid
    Adrenaline
    2023-01-31
    Japanese DMF

    Found JDMF

    226MF10196
    Adrenalin at Via Curiel 34, 20067 P...
    2014-10-27
    Written Confirmation

    Close WC

    Application Number
    25989
    R1-CEP 2013-266 - Rev 01
    226MF10196
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EPINEPHRINE
    Adrenaline
    Adrenalin at Via Curiel 34, 20067 P...
    Issue/Submission Date
    2012-04-13
    2023-01-31
    2014-10-27
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    • FDA
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    Fentanyl

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    USDMF

    Found USDMF

    16872
    Active
    FENTANYL
    2003-09-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-288 - Rev 03
    Valid
    Fentanyl
    2020-05-25
    Japanese DMF

    Found JDMF

    222MF10279
    Fentanyl at 1205 11th Street, Charl...
    2010-12-24
    Written Confirmation

    Close WC

    Application Number
    16872
    R1-CEP 2004-288 - Rev 03
    222MF10279
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FENTANYL
    Fentanyl
    Fentanyl at 1205 11th Street, Charl...
    Issue/Submission Date
    2003-09-26
    2020-05-25
    2010-12-24
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    • FDA
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    Hydrochlorothiazide

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    USDMF

    Found USDMF

    881
    Active
    HYDROCHLOROTHIAZIDE
    1965-01-02
    CEP/COS

    Found CEP/COS

    CEP 2004-307 - Rev 07
    Valid
    Hydrochlorothiazide
    2024-02-23
    Japanese DMF

    Found JDMF

    219MF10334
    Hydrochlorothiazide at Via Curiel 3...
    2007-11-20
    Written Confirmation

    Close WC

    Application Number
    881
    CEP 2004-307 - Rev 07
    219MF10334
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROCHLOROTHIAZIDE
    Hydrochlorothiazide
    Hydrochlorothiazide at Via Curiel 3...
    Issue/Submission Date
    1965-01-02
    2024-02-23
    2007-11-20
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    • FDA
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    Lidocaine

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    USDMF

    Found USDMF

    19532
    Active
    LIDOCAINE
    2006-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-326 - Rev 00
    Valid
    Lidocaine
    2018-05-17
    Japanese DMF

    Found JDMF

    222MF10045
    Lidocaine at SE-691 85 Karlskoga, S...
    2010-02-09
    Written Confirmation

    Close WC

    Application Number
    19532
    R1-CEP 2011-326 - Rev 00
    222MF10045
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LIDOCAINE
    Lidocaine
    Lidocaine at SE-691 85 Karlskoga, S...
    Issue/Submission Date
    2006-04-30
    2018-05-17
    2010-02-09
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    Lidocaine Hydrochloride

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    USDMF

    Found USDMF

    19531
    Active
    LIDOCAINE HYDROCHLORIDE
    2006-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-325 - Rev 02
    Valid
    Lidocaine hydrochloride monohydrate
    2021-06-22
    Japanese DMF

    Found JDMF

    218MF10963
    Lidocaine hydrochloride at SE-691 8...
    2006-12-01
    Written Confirmation

    Close WC

    Application Number
    19531
    R1-CEP 2011-325 - Rev 02
    218MF10963
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LIDOCAINE HYDROCHLORIDE
    Lidocaine hydrochloride monohydrate
    Lidocaine hydrochloride at SE-691 8...
    Issue/Submission Date
    2006-04-30
    2021-06-22
    2006-12-01
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    • FDA
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    Lorazepam

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    USDMF

    Found USDMF

    4517
    Active
    LORAZEPAM
    1982-05-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-049 - Rev 02
    Valid
    Lorazepam
    2022-04-19
    Japanese DMF

    Found JDMF

    218MF10781
    Lorazepam at Via Curiel 34, 20067 P...
    2006-09-22
    Written Confirmation

    Close WC

    Application Number
    4517
    R1-CEP 2008-049 - Rev 02
    218MF10781
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LORAZEPAM
    Lorazepam
    Lorazepam at Via Curiel 34, 20067 P...
    Issue/Submission Date
    1982-05-04
    2022-04-19
    2006-09-22
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    • FDA
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    Mesalazine

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    USDMF

    Found USDMF

    5693
    Active
    MESALAMINE/5-AMINOSALICYLIC ACID
    1985-01-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-093 - Rev 03
    Valid
    Mesalazine, Grade SH
    2021-06-11
    Japanese DMF

    Found JDMF

    220MF10007
    5-amino salicylic acid, SH grade at...
    2008-01-09
    Written Confirmation

    Close WC

    Application Number
    5693
    R1-CEP 2004-093 - Rev 03
    220MF10007
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE/5-AMINOSALICYLIC ACID
    Mesalazine, Grade SH
    5-amino salicylic acid, SH grade at...
    Issue/Submission Date
    1985-01-24
    2021-06-11
    2008-01-09
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    • FDA
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    Midazolam

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    USDMF

    Found USDMF

    12686
    Active
    MIDAZOLAM
    1997-10-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-025 - Rev 03
    Valid
    Midazolam
    2017-07-28
    Japanese DMF

    Found JDMF

    223MF10029
    Midazolam at Via Curiel 34, 20067 P...
    2011-02-25
    Written Confirmation

    Close WC

    Application Number
    12686
    R1-CEP 2006-025 - Rev 03
    223MF10029
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MIDAZOLAM
    Midazolam
    Midazolam at Via Curiel 34, 20067 P...
    Issue/Submission Date
    1997-10-06
    2017-07-28
    2011-02-25
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    • FDA
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    15752
    Active
    ONDANSETRON HCL
    2001-12-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-130 - Rev 01
    Valid
    Ondansetron hydrochloride dihydrate
    2011-12-12
    Japanese DMF

    Found JDMF

    219MF10374
    Ondansetron hydrochloride at 1205 1...
    2007-12-19
    Written Confirmation

    Close WC

    Application Number
    15752
    R1-CEP 2003-130 - Rev 01
    219MF10374
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ONDANSETRON HCL
    Ondansetron hydrochloride dihydrate
    Ondansetron hydrochloride at 1205 1...
    Issue/Submission Date
    2001-12-05
    2011-12-12
    2007-12-19
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    • FDA
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    Rivastigmine

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    USDMF

    Found USDMF

    29826
    Active
    RIVASTIGMINE
    2015-09-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-291 - Rev 01
    Valid
    Rivastigmine
    2023-05-30
    Japanese DMF

    Found JDMF

    303MF10138
    Rivastigmine at SE-691 85 Karlskoga...
    2021-08-25
    Written Confirmation

    Close WC

    Application Number
    29826
    R1-CEP 2014-291 - Rev 01
    303MF10138
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVASTIGMINE
    Rivastigmine
    Rivastigmine at SE-691 85 Karlskoga...
    Issue/Submission Date
    2015-09-08
    2023-05-30
    2021-08-25
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    • FDA
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    Sodium Cromoglicate

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    USDMF

    Found USDMF

    8164
    Active
    CROMOLYN SODIUM / SODIUM CROMOGLICA...
    1989-08-02
    CEP/COS

    Found CEP/COS

    CEP 2006-055 - Rev 03
    Valid
    Sodium cromoglicate
    2024-02-19
    Japanese DMF

    Found JDMF

    217MF11184
    Sodium cromoglycate at Via Curiel 3...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    8164
    CEP 2006-055 - Rev 03
    217MF11184
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CROMOLYN SODIUM / SODIUM CROMOGLICA...
    Sodium cromoglicate
    Sodium cromoglycate at Via Curiel 3...
    Issue/Submission Date
    1989-08-02
    2024-02-19
    2005-12-12
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    • FDA
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    Alprazolam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7094
    Active
    ALPRAZOLAM
    1987-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10715
    Alprazolam at Via Curiel 34, 20067 ...
    2006-08-14
    Written Confirmation

    Close WC

    Application Number
    7094
    218MF10715
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ALPRAZOLAM
    Alprazolam at Via Curiel 34, 20067 ...
    Issue/Submission Date
    1987-08-04
    2006-08-14
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    • FDA
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    Amphetamine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15307
    Active
    DEXTROAMPHETAMINE SULFATE USP
    2001-02-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-478 - Rev 00
    Valid
    Dexamfetamine sulfate
    2023-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15307
    R0-CEP 2021-478 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEXTROAMPHETAMINE SULFATE USP
    Dexamfetamine sulfate
    Issue/Submission Date
    2001-02-26
    2023-06-15
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    • FDA
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    Aripiprazole

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    USDMF

    Found USDMF

    18774
    Active
    ARIPIPRAZOLE
    2005-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10233
    Purification aripiprazole at Via Cu...
    2015-09-24
    Written Confirmation

    Close WC

    Application Number
    18774
    227MF10233
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARIPIPRAZOLE
    Purification aripiprazole at Via Cu...
    Issue/Submission Date
    2005-09-13
    2015-09-24
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    • FDA
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    Benzoyl Peroxide

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    USDMF

    Found USDMF

    15218
    Active
    HYDROUS BENZOYL PEROXIDE
    2000-12-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-118 - Rev 02
    Valid
    Benzoyl Peroxide, Hydrous
    2020-05-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15218
    R1-CEP 2009-118 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROUS BENZOYL PEROXIDE
    Benzoyl Peroxide, Hydrous
    Issue/Submission Date
    2000-12-27
    2020-05-20
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    • FDA
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    Bisacodyl

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    USDMF

    Found USDMF

    2248
    Active
    BISACODYL
    1974-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10142
    Bisacodyl at Via Curiel 34, 20067 P...
    2006-01-31
    Written Confirmation

    Close WC

    Application Number
    2248
    218MF10142
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BISACODYL
    Bisacodyl at Via Curiel 34, 20067 P...
    Issue/Submission Date
    1974-03-21
    2006-01-31
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    Chlordiazepoxide

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    USDMF

    Found USDMF

    745
    Active
    CHLORDIAZEPOXIDE HYDROCHLORIDE
    1963-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10145
    Chlordiazepoxide at Via Curiel 34, ...
    2006-01-31
    Written Confirmation

    Close WC

    Application Number
    745
    218MF10145
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CHLORDIAZEPOXIDE HYDROCHLORIDE
    Chlordiazepoxide at Via Curiel 34, ...
    Issue/Submission Date
    1963-12-02
    2006-01-31
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    Clorazepate Dipotassium

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    USDMF

    Found USDMF

    4240
    Active
    CLORAZEPATE DIPOTASSIUM
    1981-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10063
    Clorazepate dipotassium at Via Curi...
    2007-03-05
    Written Confirmation

    Close WC

    Application Number
    4240
    219MF10063
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLORAZEPATE DIPOTASSIUM
    Clorazepate dipotassium at Via Curi...
    Issue/Submission Date
    1981-06-26
    2007-03-05
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    Clozapine

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    USDMF

    Found USDMF

    11692
    Active
    CLOZAPINE
    1995-10-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-128 - Rev 03
    Valid
    Clozapine
    2022-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11692
    R1-CEP 2005-128 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLOZAPINE
    Clozapine
    Issue/Submission Date
    1995-10-03
    2022-05-31
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    Cysteamine Bitartrate

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    USDMF

    Found USDMF

    9619
    Active
    CYSTEAMINE BITARTRATE
    1992-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10146
    Cysteamine bitartrate at Via Curiel...
    2013-07-25
    Written Confirmation

    Close WC

    Application Number
    9619
    225MF10146
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CYSTEAMINE BITARTRATE
    Cysteamine bitartrate at Via Curiel...
    Issue/Submission Date
    1992-09-30
    2013-07-25
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    Diazepam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    1478
    Active
    DIAZEPAM
    1970-02-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10146
    Diazepam at Via Curiel 34, 20067 Pa...
    2006-01-31
    Written Confirmation

    Close WC

    Application Number
    1478
    218MF10146
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIAZEPAM
    Diazepam at Via Curiel 34, 20067 Pa...
    Issue/Submission Date
    1970-02-03
    2006-01-31
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    Epinephrine Bitartrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28385
    Active
    EPINEPHRINE BITARTRATE
    2014-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-221 - Rev 00
    Valid
    Adrenaline tartrate
    2020-05-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28385
    R1-CEP 2013-221 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EPINEPHRINE BITARTRATE
    Adrenaline tartrate
    Issue/Submission Date
    2014-06-03
    2020-05-12
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    • FDA
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    Estazolam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12228
    Active
    ESTAZOLAM
    1996-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10060
    Estazolam at Via Curiel 34, 20067 P...
    2010-02-17
    Written Confirmation

    Close WC

    Application Number
    12228
    222MF10060
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ESTAZOLAM
    Estazolam at Via Curiel 34, 20067 P...
    Issue/Submission Date
    1996-11-18
    2010-02-17
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    Fentanyl Citrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17055
    Active
    FENTANYL CITRATE USP
    2003-12-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-288 - Rev 01
    Valid
    Fentanyl citrate
    2019-09-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17055
    R1-CEP 2006-288 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FENTANYL CITRATE USP
    Fentanyl citrate
    Issue/Submission Date
    2003-12-19
    2019-09-24
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    Glibenclamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    7675
    Active
    GLYBURIDE
    1988-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10129
    Glibenclamide at Via Curiel 34, 200...
    2020-10-21
    Written Confirmation

    Close WC

    Application Number
    7675
    302MF10129
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYBURIDE
    Glibenclamide at Via Curiel 34, 200...
    Issue/Submission Date
    1988-09-16
    2020-10-21
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29763
    Active
    LACOSAMIDE
    2015-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-184 - Rev 00
    Valid
    Lacosamide
    2022-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29763
    R0-CEP 2019-184 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LACOSAMIDE
    Lacosamide
    Issue/Submission Date
    2015-09-07
    2022-03-29
    ASK
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    Lormetazepam

    PDF Supplier PDF
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    USDMF

    Found USDMF

    4195
    Active
    LORMETAZEPAM
    1981-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10036
    Lormetazepam at Via Curiel 34, 2006...
    2016-02-02
    Written Confirmation

    Close WC

    Application Number
    4195
    228MF10036
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LORMETAZEPAM
    Lormetazepam at Via Curiel 34, 2006...
    Issue/Submission Date
    1981-05-11
    2016-02-02
    ASK
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    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    7655
    Active
    5-AMINOSALICYLIC ACID
    1988-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-071 - Rev 03
    Valid
    Mesalazine, Grade S
    2021-06-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7655
    R1-CEP 2003-071 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    5-AMINOSALICYLIC ACID
    Mesalazine, Grade S
    Issue/Submission Date
    1988-09-01
    2021-06-14
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    Nicotine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16166
    Active
    NICOTINE POLACRILEX, 15%, USP
    2002-10-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-089 - Rev 02
    Valid
    Nicotine resinate, Nicotine content...
    2022-03-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16166
    R1-CEP 2008-089 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NICOTINE POLACRILEX, 15%, USP
    Nicotine resinate, Nicotine content...
    Issue/Submission Date
    2002-10-01
    2022-03-15
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    Nicotine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21756
    Active
    NICOTINE RESINATE, 20%
    2008-07-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-171 - Rev 01
    Valid
    Nicotine resinate, Nicotine content...
    2015-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21756
    R1-CEP 2008-171 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NICOTINE RESINATE, 20%
    Nicotine resinate, Nicotine content...
    Issue/Submission Date
    2008-07-01
    2015-02-05
    ASK
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    Norepinephrine Bitartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    12037
    Active
    NOREPINEPHRINE BITARTRATE/NORADRENA...
    1996-07-10
    CEP/COS

    Found CEP/COS

    CEP 2009-006 - Rev 03
    Valid
    Noradrenaline tartrate
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12037
    CEP 2009-006 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NOREPINEPHRINE BITARTRATE/NORADRENA...
    Noradrenaline tartrate
    Issue/Submission Date
    1996-07-10
    2023-11-08
    ASK
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    • FDA
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    Raloxifene Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22927
    Active
    RALOXIFENE HYDROCHLORIDE
    2009-07-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10039
    Raloxifene hydrochloride at Via Cur...
    2015-02-09
    Written Confirmation

    Close WC

    Application Number
    22927
    227MF10039
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RALOXIFENE HYDROCHLORIDE
    Raloxifene hydrochloride at Via Cur...
    Issue/Submission Date
    2009-07-07
    2015-02-09
    ASK
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    • FDA
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    Rifaximin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31114
    Active
    RIFAXIMIN
    2016-11-04
    CEP/COS

    Found CEP/COS

    CEP 2020-435 - Rev 00
    Valid
    Rifaximin
    2024-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31114
    CEP 2020-435 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIFAXIMIN
    Rifaximin
    Issue/Submission Date
    2016-11-04
    2024-02-12
    ASK
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    • FDA
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    Salbutamol Sulphate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    6522
    Active
    ALBUTEROL / SALBUTAMOL SULPHATE
    1986-08-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10285
    Salbutamol sulphate at Via Curiel 3...
    2007-09-10
    Written Confirmation

    Close WC

    Application Number
    6522
    219MF10285
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ALBUTEROL / SALBUTAMOL SULPHATE
    Salbutamol sulphate at Via Curiel 3...
    Issue/Submission Date
    1986-08-07
    2007-09-10
    ASK
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    • FDA
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    Sodium Picosulfate

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

    See Less

    USDMF

    Found USDMF

    23477
    Active
    SODIUM PICOSULFATE
    2010-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11185
    Pico sulfate sodium at Via Curiel 3...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    23477
    217MF11185
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM PICOSULFATE
    Pico sulfate sodium at Via Curiel 3...
    Issue/Submission Date
    2010-01-18
    2005-12-12
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    • FDA
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    Sotalol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12273
    Active
    SOTALOL HCL
    1996-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10102
    Sotalol Hydrochloride at Via Curiel...
    2020-08-18
    Written Confirmation

    Close WC

    Application Number
    12273
    302MF10102
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SOTALOL HCL
    Sotalol Hydrochloride at Via Curiel...
    Issue/Submission Date
    1996-12-17
    2020-08-18
    ASK
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    • FDA
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    Sulfasalazine

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-040 - Rev 02
    Valid
    Sulfasalazine
    2007-08-30
    Japanese DMF

    Found JDMF

    219MF10098
    Sulfasalazine at 1205 11th Street, ...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-040 - Rev 02
    219MF10098
    Status
    Valid
     
    Filing Details
    Sulfasalazine
    Sulfasalazine at 1205 11th Street, ...
    Issue/Submission Date
    2007-08-30
    2007-03-14
    ASK
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    • FDA
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    Torsemide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17489
    Active
    TORSEMIDE USP
    2004-06-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-111 - Rev 00
    Valid
    Torasemide
    2012-02-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17489
    R1-CEP 2005-111 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TORSEMIDE USP
    Torasemide
    Issue/Submission Date
    2004-06-21
    2012-02-17
    ASK
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    Triazolam

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    8704
    Active
    TRIAZOLAM
    1990-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11186
    Triazolam at Via Curiel 34, 20067 P...
    2005-12-12
    Written Confirmation

    Close WC

    Application Number
    8704
    217MF11186
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TRIAZOLAM
    Triazolam at Via Curiel 34, 20067 P...
    Issue/Submission Date
    1990-08-06
    2005-12-12
    ASK
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    • FDA
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    Zolpidem Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17098
    Active
    ZOLPIDEM TARTRATE
    2003-12-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-035 - Rev 04
    Valid
    Zolpidem tartrate
    2020-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17098
    R1-CEP 2005-035 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ZOLPIDEM TARTRATE
    Zolpidem tartrate
    Issue/Submission Date
    2003-12-12
    2020-11-27
    ASK
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    • FDA
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    Ofloxacin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    14928
    Active
    OFLOXACIN USP
    2000-06-19
    CEP/COS

    Caution CEP/COS

    R0-CEP 2002-029 - Rev 01
    Expired
    Ofloxacin
    2004-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14928
    R0-CEP 2002-029 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    OFLOXACIN USP
    Ofloxacin
    Issue/Submission Date
    2000-06-19
    2004-10-13
    ASK
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    • FDA
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    Amphetamine

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

    See Less

    USDMF

    Found USDMF

    15308
    Active
    AMPHETAMINE SULFATE
    2001-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15308
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMPHETAMINE SULFATE
    Issue/Submission Date
    2001-02-26
    ASK
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    Amphetamine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15338
    Active
    PURIFIED D-AMPHETAMINE BASE
    2001-02-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15338
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PURIFIED D-AMPHETAMINE BASE
    Issue/Submission Date
    2001-02-21
    ASK
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    • FDA
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    Amphetamine Aspartate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    15306
    Active
    AMPHETAMINE ASPARTATE MONOHYDRATE
    2001-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15306
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMPHETAMINE ASPARTATE MONOHYDRATE
    Issue/Submission Date
    2001-02-26
    ASK
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    • FDA
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    Clonazepam

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    11351
    Active
    CLONAZEPAM
    1995-02-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11351
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLONAZEPAM
    Issue/Submission Date
    1995-02-17
    ASK
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    Dextroamphetamine Saccharate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15305
    Active
    DEXTROAMPHETAMINE SACCHARATE
    2001-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15305
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROAMPHETAMINE SACCHARATE
    Issue/Submission Date
    2001-02-26
    ASK
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    • FDA
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    Labetalol Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12758
    Active
    LABETALOL HYDROCHLORIDE
    1997-11-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Application Number
    12758
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LABETALOL HYDROCHLORIDE
    Issue/Submission Date
    1997-11-24
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    11927
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    TERBUTALINE SULFATE
    1996-04-17
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    Application Number
    11927
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERBUTALINE SULFATE
    Issue/Submission Date
    1996-04-17
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