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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Mallinckrodt Pharmaceuticals

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    Mallinckrodt Pharmaceuticals
    Ireland Flag
    Country
    Country
    Ireland
    Address
    Address
    College Business & Technology Park Cruiserath, Blanchardstown Dublin 15
    Telephone
    Telephone
    +353 1 6960000
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.mallinckrodt.com/
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    Paracetamol

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    USDMF

    Found USDMF

    4203
    Active
    COMPAP™
    1981-06-12
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-039 - Rev 04
    Valid
    Paracetamol
    2018-04-25
    Japanese DMF

    Found JDMF

    218MF10905
    Acetaminophen at 385 Marshall Ave, ...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    4203
    R1-CEP 1996-039 - Rev 04
    218MF10905
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    COMPAP™
    Paracetamol
    Acetaminophen at 385 Marshall Ave, ...
    Issue/Submission Date
    1981-06-12
    2018-04-25
    2006-11-10
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    Fentanyl

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    USDMF

    Caution USDMF

    8074
    Inactive
    FENTANYL ALKALOID
    1989-05-11
    CEP/COS

    Found CEP/COS

    CEP 2005-260 - Rev 03
    Valid
    Fentanyl
    2024-02-14
    Japanese DMF

    Found JDMF

    221MF10283
    Fentanyl at 385 Marshall Ave, Webst...
    2009-12-22
    Written Confirmation

    Close WC

    Application Number
    8074
    CEP 2005-260 - Rev 03
    221MF10283
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FENTANYL ALKALOID
    Fentanyl
    Fentanyl at 385 Marshall Ave, Webst...
    Issue/Submission Date
    1989-05-11
    2024-02-14
    2009-12-22
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    Fentanyl Citrate

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    USDMF

    Caution USDMF

    7051
    Inactive
    FENTANYL CITRATE USP
    1987-07-02
    CEP/COS

    Found CEP/COS

    CEP 2009-097 - Rev 02
    Valid
    Fentanyl citrate
    2024-01-30
    Japanese DMF

    Found JDMF

    229MF10161
    Fentanyl citrate FP at 385 Marshall...
    2017-08-17
    Written Confirmation

    Close WC

    Application Number
    7051
    CEP 2009-097 - Rev 02
    229MF10161
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FENTANYL CITRATE USP
    Fentanyl citrate
    Fentanyl citrate FP at 385 Marshall...
    Issue/Submission Date
    1987-07-02
    2024-01-30
    2017-08-17
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    Amphetamine

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    USDMF

    Found USDMF

    15385
    Active
    DEXTROAMPHETAMINE SULFATE USP
    2001-04-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-076 - Rev 00
    Valid
    Dexamfetamine sulfate
    2021-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15385
    R0-CEP 2020-076 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DEXTROAMPHETAMINE SULFATE USP
    Dexamfetamine sulfate
    Issue/Submission Date
    2001-04-18
    2021-07-26
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    Buprenorphine

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    USDMF

    Found USDMF

    24928
    Active
    BUPRENORPHINE BASE EP, CODE 3205
    2012-05-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-098 - Rev 00
    Valid
    Buprenorphine
    2021-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24928
    R1-CEP 2013-098 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUPRENORPHINE BASE EP, CODE 3205
    Buprenorphine
    Issue/Submission Date
    2012-05-02
    2021-06-24
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    Buprenorphine Hydrochloride

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    USDMF

    Found USDMF

    24927
    Active
    BUPRENORPHINE HYDROCHLORIDE USP, CO...
    2012-05-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-048 - Rev 00
    Valid
    Buprenorphine hydrochloride
    2021-05-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24927
    R1-CEP 2013-048 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUPRENORPHINE HYDROCHLORIDE USP, CO...
    Buprenorphine hydrochloride
    Issue/Submission Date
    2012-05-02
    2021-05-04
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    Buprenorphine Hydrochloride

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    USDMF

    Found USDMF

    26366
    Active
    NORBUPRENORPHINE HYDROCHLORIDE
    2012-11-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-107 - Rev 00
    Valid
    Buprenorphine hydrochloride, Proces...
    2023-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26366
    R0-CEP 2023-107 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NORBUPRENORPHINE HYDROCHLORIDE
    Buprenorphine hydrochloride, Proces...
    Issue/Submission Date
    2012-11-27
    2023-08-24
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    Codeine Phosphate

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    USDMF

    Found USDMF

    4839
    Active
    CODEINE PHOSPHATE
    1983-03-11
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-152 - Rev 04
    Valid
    Codeine phosphate hemihydrate
    2018-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4839
    R1-CEP 1999-152 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CODEINE PHOSPHATE
    Codeine phosphate hemihydrate
    Issue/Submission Date
    1983-03-11
    2018-10-04
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    Fentanyl Citrate

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    USDMF

    Found USDMF

    10128
    Active
    FENTANYL CITRATE (NEW PROCESS)
    1993-03-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10580
    Fentanyl citrate at 385 Marshall Av...
    2006-06-22
    Written Confirmation

    Close WC

    Application Number
    10128
    218MF10580
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FENTANYL CITRATE (NEW PROCESS)
    Fentanyl citrate at 385 Marshall Av...
    Issue/Submission Date
    1993-03-15
    2006-06-22
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    Ioversol

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    USDMF

    Found USDMF

    6972
    Active
    IOVERSOL
    1987-05-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10059
    Ioversol at Damastown, Mulhuddart, ...
    2014-03-06
    Written Confirmation

    Close WC

    Application Number
    6972
    226MF10059
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IOVERSOL
    Ioversol at Damastown, Mulhuddart, ...
    Issue/Submission Date
    1987-05-13
    2014-03-06
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    Methylphenidate Hydrochloride

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    USDMF

    Found USDMF

    12769
    Active
    METHYLPHENIDATE HYDROCHLORIDE USP
    1997-11-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-140 - Rev 01
    Valid
    Methylphenidate hydrochloride
    2018-02-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12769
    R1-CEP 2009-140 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE USP
    Methylphenidate hydrochloride
    Issue/Submission Date
    1997-11-25
    2018-02-06
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    Methylphenidate Hydrochloride

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    USDMF

    Found USDMF

    25776
    Active
    METHYLPHENIDATE HYDROCHLORIDE USP (...
    2013-09-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-005 - Rev 00
    Valid
    Methylphenidate hydrochloride, Proc...
    2022-03-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25776
    R0-CEP 2020-005 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METHYLPHENIDATE HYDROCHLORIDE USP (...
    Methylphenidate hydrochloride, Proc...
    Issue/Submission Date
    2013-09-30
    2022-03-24
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    Naloxone Hydrochloride

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    USDMF

    Found USDMF

    1862
    Active
    NALOXONE HCL USP DIHYDRATE
    1972-01-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-294 - Rev 01
    Valid
    Naloxone hydrochloride dihydrate, C...
    2023-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    1862
    R1-CEP 2009-294 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NALOXONE HCL USP DIHYDRATE
    Naloxone hydrochloride dihydrate, C...
    Issue/Submission Date
    1972-01-25
    2023-08-08
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    Naltrexone Hydrochloride

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    USDMF

    Found USDMF

    6265
    Active
    NALTREXONE HCL
    1986-04-11
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-218 - Rev 01
    Valid
    Naltrexone hydrochloride
    2022-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6265
    R0-CEP 2018-218 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NALTREXONE HCL
    Naltrexone hydrochloride
    Issue/Submission Date
    1986-04-11
    2022-08-09
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    Pethidine Hydrochloride

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    USDMF

    Found USDMF

    11345
    Active
    MEPERIDINE HYDROCHLORIDE, USP
    1995-02-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10904
    Pethidine hydrochloride at 385 Mars...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    11345
    218MF10904
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEPERIDINE HYDROCHLORIDE, USP
    Pethidine hydrochloride at 385 Mars...
    Issue/Submission Date
    1995-02-10
    2006-11-10
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    Sufentanil Citrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12183
    Active
    SUFENTANIL BASE CODE 0310
    1996-10-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-095 - Rev 00
    Valid
    Sufentanil citrate
    2018-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12183
    R0-CEP 2017-095 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SUFENTANIL BASE CODE 0310
    Sufentanil citrate
    Issue/Submission Date
    1996-10-21
    2018-12-20
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    Sufentanil Citrate

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    USDMF

    Found USDMF

    14505
    Active
    SUFENTANIL CITRATE USP
    1999-10-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-054 - Rev 00
    Valid
    Sufentanil
    2021-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14505
    R0-CEP 2019-054 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SUFENTANIL CITRATE USP
    Sufentanil
    Issue/Submission Date
    1999-10-27
    2021-01-20
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    Calcium Stearate API

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    2355
    Inactive
    STEAR-O-WET C (CALCIUM STEARATE)
    1974-11-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-177 - Rev 01
    Valid
    Calcium stearate, (Code numbers 224...
    2006-11-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2355
    R1-CEP 2000-177 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STEAR-O-WET C (CALCIUM STEARATE)
    Calcium stearate, (Code numbers 224...
    Issue/Submission Date
    1974-11-19
    2006-11-15
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    Exenatide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17114
    Inactive
    EXENATIDE
    2004-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10169
    Exenatide at 385 Marshall Ave, Webs...
    2009-07-30
    Written Confirmation

    Close WC

    Application Number
    17114
    221MF10169
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    EXENATIDE
    Exenatide at 385 Marshall Ave, Webs...
    Issue/Submission Date
    2004-01-19
    2009-07-30
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    Methadone Hydrochloride

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    USDMF

    Caution USDMF

    1515
    Inactive
    METHADONE HYDROCHLORIDE
    1970-04-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10179
    Methadone hydrochloride at 385 Mars...
    2011-12-27
    Written Confirmation

    Close WC

    Application Number
    1515
    223MF10179
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METHADONE HYDROCHLORIDE
    Methadone hydrochloride at 385 Mars...
    Issue/Submission Date
    1970-04-23
    2011-12-27
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    Oxycodone Hydrochloride

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    USDMF

    Caution USDMF

    2821
    Inactive
    OXYCODONE HYDROCHLORIDE PURIFIED RE...
    1977-01-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-375 - Rev 00
    Valid
    Oxycodone hydrochloride
    2023-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2821
    R0-CEP 2021-375 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXYCODONE HYDROCHLORIDE PURIFIED RE...
    Oxycodone hydrochloride
    Issue/Submission Date
    1977-01-04
    2023-02-14
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    Amphetamine

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    USDMF

    Found USDMF

    15425
    Active
    AMPHETAMINE SULFATE
    2001-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15425
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMPHETAMINE SULFATE
    Issue/Submission Date
    2001-05-09
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    Amphetamine

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    USDMF

    Found USDMF

    16567
    Active
    DEXTROAMPHETAMINE BASE
    2003-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16567
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEXTROAMPHETAMINE BASE
    Issue/Submission Date
    2003-04-29
    ASK
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    Amphetamine Aspartate

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    USDMF

    Found USDMF

    15435
    Active
    AMPHETAMINE ASPARTATE
    2001-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15435
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMPHETAMINE ASPARTATE
    Issue/Submission Date
    2001-05-15
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    Chlorpheniramine

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    USDMF

    Found USDMF

    17311
    Active
    CHLORPHENIRAMINE POLISTIREX
    2004-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17311
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHLORPHENIRAMINE POLISTIREX
    Issue/Submission Date
    2004-04-01
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    Cocaine Hydrochloride

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    USDMF

    Found USDMF

    20995
    Active
    COCAINE HYDROCHLORIDE USP
    2007-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20995
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    COCAINE HYDROCHLORIDE USP
    Issue/Submission Date
    2007-11-02
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    Codeine Sulfate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21117
    Active
    CODEINE SULFATE USP POWDER
    2007-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21117
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CODEINE SULFATE USP POWDER
    Issue/Submission Date
    2007-11-30
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    Dextroamphetamine Saccharate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15428
    Active
    DEXTROAMPHETAMINE SACCHARATE
    2001-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15428
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXTROAMPHETAMINE SACCHARATE
    Issue/Submission Date
    2001-05-15
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    Dihydrocodeine Tartrate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    191
    Active
    PARZONE BITARTRATE (DIHYDROCODEINE ...
    1956-01-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    191
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PARZONE BITARTRATE (DIHYDROCODEINE ...
    Issue/Submission Date
    1956-01-24
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    Diphenoxylate Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12441
    Active
    DIPHENOXYLATE HYDROCHLORIDE USP
    1997-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12441
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIPHENOXYLATE HYDROCHLORIDE USP
    Issue/Submission Date
    1997-03-31
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    • FDA
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    Fentanyl

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    14285
    Active
    FENTANYL ALKALOID
    1999-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14285
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FENTANYL ALKALOID
    Issue/Submission Date
    1999-06-30
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    Hydrocodone Bitartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17285
    Active
    HYDROCODONE POLISTIREX
    2004-03-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17285
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDROCODONE POLISTIREX
    Issue/Submission Date
    2004-03-25
    ASK
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    Ibuprofen

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

    See Less

    USDMF

    Found USDMF

    17036
    Active
    DCI™-63 (IBUPROFEN USP 63%)
    2003-12-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17036
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DCI™-63 (IBUPROFEN USP 63%)
    Issue/Submission Date
    2003-12-17
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    Ioversol

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12259
    Active
    IOVERSOL, DRUG SUBSTANCE FOR OPTIRA...
    1996-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12259
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IOVERSOL, DRUG SUBSTANCE FOR OPTIRA...
    Issue/Submission Date
    1996-12-06
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    Levorphanol Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18823
    Active
    LEVORPHANOL TARTRATE USP SPECIAL
    2005-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18823
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LEVORPHANOL TARTRATE USP SPECIAL
    Issue/Submission Date
    2005-09-29
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    Levorphanol Tartrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20747
    Active
    LEVORPHANOL BASE
    2007-08-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20747
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LEVORPHANOL BASE
    Issue/Submission Date
    2007-08-02
    ASK
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    • FDA
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    Methadone

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22700
    Active
    METHADONE BASE SPECIAL
    2009-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22700
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHADONE BASE SPECIAL
    Issue/Submission Date
    2009-04-02
    ASK
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    Methylnaltrexone Bromide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22553
    Active
    METHYLNALTREXONE BROMIDE, CODE 1251
    2009-02-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22553
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METHYLNALTREXONE BROMIDE, CODE 1251
    Issue/Submission Date
    2009-02-16
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    Methylphenidate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13132
    Active
    METHYLPHENIDATE BASE
    1998-08-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13132
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METHYLPHENIDATE BASE
    Issue/Submission Date
    1998-08-12
    ASK
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    • FDA
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    Nalbuphine

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

    See Less

    USDMF

    Found USDMF

    11421
    Active
    NALBUPHINE HYDROCHLORIDE (LOW BETA ...
    1995-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11421
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NALBUPHINE HYDROCHLORIDE (LOW BETA ...
    Issue/Submission Date
    1995-03-31
    ASK
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    Nalbuphine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23604
    Active
    NALBUPHINE HYDROCHLORIDE (1P)
    2010-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23604
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NALBUPHINE HYDROCHLORIDE (1P)
    Issue/Submission Date
    2010-04-29
    ASK
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    • FDA
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    Nalmefene Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15663
    Active
    NALMEFENE HYDROCHLORIDE
    2001-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15663
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NALMEFENE HYDROCHLORIDE
    Issue/Submission Date
    2001-10-10
    ASK
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    • FDA
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    Noscapine

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

    See Less

    USDMF

    Found USDMF

    14626
    Active
    NOSCAPINE USP SMALL CRYSTALS CODE 6...
    1999-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14626
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NOSCAPINE USP SMALL CRYSTALS CODE 6...
    Issue/Submission Date
    1999-12-16
    ASK
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    • FDA
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    Opium

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

    See Less

    USDMF

    Found USDMF

    23883
    Active
    OPIUM TINCTURE 2%
    2010-08-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23883
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OPIUM TINCTURE 2%
    Issue/Submission Date
    2010-08-04
    ASK
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    • FDA
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    Oxycodone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19898
    Active
    OXYCODONE BASE - CODE 8180
    2006-10-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19898
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OXYCODONE BASE - CODE 8180
    Issue/Submission Date
    2006-10-17
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    • FDA
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    Oxymorphone

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    21372
    Active
    OXYMORPHONE BASE
    2008-02-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21372
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OXYMORPHONE BASE
    Issue/Submission Date
    2008-02-18
    ASK
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    Oxymorphone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    14502
    Active
    OXYMORPHONE HYDROCHLORIDE USP
    1999-10-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14502
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OXYMORPHONE HYDROCHLORIDE USP
    Issue/Submission Date
    1999-10-29
    ASK
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    • FDA
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    Paracetamol

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

    See Less

    USDMF

    Found USDMF

    12237
    Active
    COMPAP WSE, CODE 2907
    1996-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12237
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPAP WSE, CODE 2907
    Issue/Submission Date
    1996-11-18
    ASK
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    • FDA
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    Paracetamol

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

    See Less

    USDMF

    Found USDMF

    18508
    Active
    COMPAP™ COURSE L
    2005-07-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18508
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    COMPAP™ COURSE L
    Issue/Submission Date
    2005-07-06
    ASK
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    • FDA
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    Sodium Molybdate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12103
    Active
    SODIUM MOLYBDATE (99MO)
    1996-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12103
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM MOLYBDATE (99MO)
    Issue/Submission Date
    1996-08-28
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