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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by ACS DOBFAR SPA

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    ACS DOBFAR SPA
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    Country
    Italy
    Address
    Address
    Viale Addetta 4/12 20067 Tribiano (Milan)
    Telephone
    Telephone
    +39-029-069-31
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    enquiries@pharmacompass.com
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    https://www.acsdobfar.it/
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    • FDA
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    Ampicillin Sodium

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    USDMF

    Found USDMF

    13661
    Active
    AMPICILLIN SODIUM (STERILE BULK)
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 2004-303 - Rev 03
    Valid
    Ampicillin sodium, Sterile and bact...
    2024-01-24
    Japanese DMF

    Found JDMF

    219MF10051
    Ampicillin sodium at Viale Addetta,...
    2007-02-13
    Written Confirmation

    Close WC

    Application Number
    13661
    CEP 2004-303 - Rev 03
    219MF10051
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMPICILLIN SODIUM (STERILE BULK)
    Ampicillin sodium, Sterile and bact...
    Ampicillin sodium at Viale Addetta,...
    Issue/Submission Date
    1998-09-01
    2024-01-24
    2007-02-13
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    Cefaclor

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    USDMF

    Found USDMF

    13780
    Active
    CEFACLOR MONOHYDRATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-008 - Rev 04
    Valid
    Cefaclor
    2020-12-17
    Japanese DMF

    Found JDMF

    218MF10591
    Cefaclor at Viale Addetta, 4/12, 20...
    2006-06-22
    Written Confirmation

    Close WC

    Application Number
    13780
    R1-CEP 1996-008 - Rev 04
    218MF10591
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFACLOR MONOHYDRATE
    Cefaclor
    Cefaclor at Viale Addetta, 4/12, 20...
    Issue/Submission Date
    1998-09-01
    2020-12-17
    2006-06-22
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    Cefazolin Sodium

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    USDMF

    Found USDMF

    13208
    Active
    CEFAZOLIN SODIUM LYOPHILIZED (STERI...
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-083 - Rev 06
    Valid
    Cefazolin sodium, Sterile
    2019-06-17
    Japanese DMF

    Found JDMF

    222MF10020
    Cefazolin sodium at Viale Addetta, ...
    2010-01-22
    Written Confirmation

    Close WC

    Application Number
    13208
    R1-CEP 1996-083 - Rev 06
    222MF10020
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFAZOLIN SODIUM LYOPHILIZED (STERI...
    Cefazolin sodium, Sterile
    Cefazolin sodium at Viale Addetta, ...
    Issue/Submission Date
    1998-04-30
    2019-06-17
    2010-01-22
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    Amikacin Sulfate

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    USDMF

    Found USDMF

    13763
    Active
    AMIKACIN SULFATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10052
    Amikacin Sulfate at Viale Addetta, ...
    2019-08-28
    Written Confirmation

    Close WC

    Application Number
    13763
    301MF10052
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMIKACIN SULFATE
    Amikacin Sulfate at Viale Addetta, ...
    Issue/Submission Date
    1998-09-01
    2019-08-28
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    Cefepime

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    USDMF

    Found USDMF

    24395
    Active
    CEFEPIME FOR INJECTION (STERILE BUL...
    2011-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-021 - Rev 00
    Valid
    Cefepime dihydrochloride monohydrat...
    2023-07-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24395
    R0-CEP 2023-021 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFEPIME FOR INJECTION (STERILE BUL...
    Cefepime dihydrochloride monohydrat...
    Issue/Submission Date
    2011-03-31
    2023-07-27
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    Cefotaxime

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    USDMF

    Found USDMF

    14367
    Active
    CEFOTAXIME SODIUM STERILE
    1999-08-25
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-050 - Rev 03
    Valid
    Cefotaxime sodium, Sterile
    2008-02-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14367
    R1-CEP 1998-050 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFOTAXIME SODIUM STERILE
    Cefotaxime sodium, Sterile
    Issue/Submission Date
    1999-08-25
    2008-02-28
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    Ceftazidime

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    USDMF

    Found USDMF

    13683
    Active
    CEFTAZIDIME FOR INJECTION USP (STER...
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10039
    Ceftazidime Hydrate at Viale Addett...
    2023-03-23
    Written Confirmation

    Close WC

    Application Number
    13683
    305MF10039
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFTAZIDIME FOR INJECTION USP (STER...
    Ceftazidime Hydrate at Viale Addett...
    Issue/Submission Date
    1998-09-01
    2023-03-23
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    Ceftriaxone

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    USDMF

    Found USDMF

    17259
    Active
    CEFTRIAXONE SODIUM, USP (STERILE BU...
    2004-03-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-169 - Rev 01
    Valid
    Ceftriaxone sodium, sterile and bac...
    2011-02-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17259
    R1-CEP 2003-169 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFTRIAXONE SODIUM, USP (STERILE BU...
    Ceftriaxone sodium, sterile and bac...
    Issue/Submission Date
    2004-03-25
    2011-02-18
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    Ceftriaxone

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    USDMF

    Found USDMF

    17541
    Active
    CEFTRIAXONE SODIUM NON STERILE USP
    2004-07-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-393 - Rev 02
    Valid
    Ceftriaxone sodium, Sterile
    2022-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17541
    R1-CEP 2011-393 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFTRIAXONE SODIUM NON STERILE USP
    Ceftriaxone sodium, Sterile
    Issue/Submission Date
    2004-07-01
    2022-03-03
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    Cefuroxime Sodium

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    USDMF

    Found USDMF

    13205
    Active
    CEFUROXIME SODIUM (STERILE BULK)
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-007 - Rev 05
    Valid
    Cefuroxime sodium, Sterile
    2022-07-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13205
    R1-CEP 1996-007 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFUROXIME SODIUM (STERILE BULK)
    Cefuroxime sodium, Sterile
    Issue/Submission Date
    1998-04-30
    2022-07-25
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    Cephalexin Monohydrate

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    USDMF

    Found USDMF

    13588
    Active
    CEPHALEXIN MONOHYDRATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-128 - Rev 03
    Valid
    Cefalexin monohydrate, (Enzymatic p...
    2019-08-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13588
    R1-CEP 1997-128 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEPHALEXIN MONOHYDRATE
    Cefalexin monohydrate, (Enzymatic p...
    Issue/Submission Date
    1998-09-01
    2019-08-16
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    Cephalexin Monohydrate

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    USDMF

    Found USDMF

    13612
    Active
    CEPHALEXIN MONOHYDRATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 1996-099 - Rev 04
    Valid
    Cefalexin monohydrate
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13612
    CEP 1996-099 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEPHALEXIN MONOHYDRATE
    Cefalexin monohydrate
    Issue/Submission Date
    1998-09-01
    2023-12-06
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    • FDA
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    Cilastatin Sodium

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    USDMF

    Found USDMF

    21594
    Active
    CILASTATIN SODIUM (STERILE BULK)
    2008-05-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10136
    Cilastatin Sodium at Viale Addetta,...
    2022-10-05
    Written Confirmation

    Close WC

    Application Number
    21594
    304MF10136
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CILASTATIN SODIUM (STERILE BULK)
    Cilastatin Sodium at Viale Addetta,...
    Issue/Submission Date
    2008-05-05
    2022-10-05
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    • FDA
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    Clindamycin Phosphate

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    USDMF

    Found USDMF

    18705
    Active
    CLINDAMYCIN PHOSPHATE
    2005-08-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-033 - Rev 04
    Valid
    Clindamycin phosphate, Albano plant
    2022-09-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18705
    R1-CEP 2006-033 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLINDAMYCIN PHOSPHATE
    Clindamycin phosphate, Albano plant
    Issue/Submission Date
    2005-08-08
    2022-09-01
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    • FDA
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    Meropenem

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    USDMF

    Found USDMF

    22503
    Active
    MEROPENEM FOR INJECTION
    2009-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-238 - Rev 01
    Valid
    Meropenem trihydrate, Sterile, synt...
    2022-01-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22503
    R1-CEP 2011-238 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MEROPENEM FOR INJECTION
    Meropenem trihydrate, Sterile, synt...
    Issue/Submission Date
    2009-02-04
    2022-01-20
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    Sulbactam Sodium

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    USDMF

    Found USDMF

    16452
    Active
    SULBACTAM SODIUM USP (STERILE BULK)
    2003-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10054
    Sulbactam sodium (sterile) at Viale...
    2016-02-18
    Written Confirmation

    Close WC

    Application Number
    16452
    228MF10054
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SULBACTAM SODIUM USP (STERILE BULK)
    Sulbactam sodium (sterile) at Viale...
    Issue/Submission Date
    2003-03-07
    2016-02-18
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    Clindamycin Hydrochloride

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    USDMF

    Caution USDMF

    18704
    Inactive
    CLINDAMYCIN HYDROCHLORIDE
    2005-08-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-132 - Rev 03
    Valid
    Clindamycin hydrochloride
    2018-04-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18704
    R1-CEP 2002-132 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLINDAMYCIN HYDROCHLORIDE
    Clindamycin hydrochloride
    Issue/Submission Date
    2005-08-08
    2018-04-13
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    6-Aminopenicillanic Acid

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    USDMF

    Found USDMF

    12348
    Active
    6-AMINO PENICILLANIC ACID
    1997-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12348
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    6-AMINO PENICILLANIC ACID
    Issue/Submission Date
    1997-01-31
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    7-Amino-3-[(5-Methyl-1,3,4-Thiadiazol-2-Yl)Thiomethyl]C...

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    USDMF

    Found USDMF

    11657
    Active
    7-ZACA- 7-AMINO-3-[2-(5-METBYL-1,3,...
    1995-08-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11657
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    7-ZACA- 7-AMINO-3-[2-(5-METBYL-1,3,...
    Issue/Submission Date
    1995-08-18
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    Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazolepropionic Aci...

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    USDMF

    Found USDMF

    23418
    Active
    AMPA
    2009-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23418
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPA
    Issue/Submission Date
    2009-12-31
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    Amikacin

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    USDMF

    Found USDMF

    13762
    Active
    AMIKACIN BASE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13762
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMIKACIN BASE
    Issue/Submission Date
    1998-09-01
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    13549
    Active
    AMOXICILLIN
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13549
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMOXICILLIN
    Issue/Submission Date
    1998-09-01
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    Ampicillin Sodium

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    USDMF

    Found USDMF

    16451
    Active
    AMPICILLIN AND SULBACTAM (STERILE B...
    2003-03-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16451
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPICILLIN AND SULBACTAM (STERILE B...
    Issue/Submission Date
    2003-03-07
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    13440
    Active
    AMPICILLIN TRIHYDRATE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13440
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Issue/Submission Date
    1998-09-01
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    Carbopol 940 API

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17627
    Active
    STERILE SODIUM CARBONATE
    2004-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17627
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    STERILE SODIUM CARBONATE
    Issue/Submission Date
    2004-09-29
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    Cefadroxil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13225
    Active
    CEFADROXIL MONOHYDRATE
    1998-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13225
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFADROXIL MONOHYDRATE
    Issue/Submission Date
    1998-04-30
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    Cefalotin sodium Sterile

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12586
    Active
    CEPHALOTHIN SODIUM, ORAL GRADE
    1997-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12586
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEPHALOTHIN SODIUM, ORAL GRADE
    Issue/Submission Date
    1997-07-09
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    Cefazolin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    10303
    Active
    ACID CEFAZOLIN (INTERMEDIATE GRADE)
    1987-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10303
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ACID CEFAZOLIN (INTERMEDIATE GRADE)
    Issue/Submission Date
    1987-04-01
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    Cefepime

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19806
    Active
    CEFEPIME FOR INJECTION USP (STERILE...
    2006-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19806
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CEFEPIME FOR INJECTION USP (STERILE...
    Issue/Submission Date
    2006-09-26
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    Cefepime Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    19798
    Active
    CRUDE CEFEPIME HYDROCHLORIDE
    2006-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19798
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CRUDE CEFEPIME HYDROCHLORIDE
    Issue/Submission Date
    2006-09-26
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    Cefepime Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19927
    Active
    CEFEPIME HYDROCHLORIDE ORAL GRADE
    2006-11-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19927
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFEPIME HYDROCHLORIDE ORAL GRADE
    Issue/Submission Date
    2006-11-01
    ASK
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    • FDA
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    Cefotaxime

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15272
    Active
    CEFOTAXIME ACID
    2001-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15272
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFOTAXIME ACID
    Issue/Submission Date
    2001-01-30
    ASK
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    Cefotetan

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    19167
    Active
    ACID CEFOTETAN
    2006-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19167
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ACID CEFOTETAN
    Issue/Submission Date
    2006-02-08
    ASK
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    Cefotetan Disodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    18977
    Active
    CEFOTETAN DISODIUM (STERILE BULK)
    2005-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18977
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFOTETAN DISODIUM (STERILE BULK)
    Issue/Submission Date
    2005-11-28
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    Cefoxitin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    11823
    Active
    CEFOXITIN ACID
    1996-01-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11823
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFOXITIN ACID
    Issue/Submission Date
    1996-01-23
    ASK
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    Cefoxitin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12976
    Active
    CEFOXITIN SODIUM (STERILE BULK)
    1998-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12976
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFOXITIN SODIUM (STERILE BULK)
    Issue/Submission Date
    1998-04-30
    ASK
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    • FDA
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    Ceftaroline Fosamil

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    23167
    Active
    CEFTAROLINE FOSAMIL STERILE DRUG SU...
    2009-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23167
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFTAROLINE FOSAMIL STERILE DRUG SU...
    Issue/Submission Date
    2009-10-09
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    • FDA
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    Ceftazidime

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    17628
    Active
    CEFTAZIDIME DIHYDROCHLORIDE
    2004-08-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17628
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFTAZIDIME DIHYDROCHLORIDE
    Issue/Submission Date
    2004-08-17
    ASK
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    • FDA
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    Cefuroxime Axetil

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    10154
    Active
    CEFUROXIME ACID
    1991-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10154
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFUROXIME ACID
    Issue/Submission Date
    1991-03-01
    ASK
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    Cephapirin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    11757
    Active
    CEPHAPIRIN ACID
    1995-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11757
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEPHAPIRIN ACID
    Issue/Submission Date
    1995-11-09
    ASK
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    Cephapirin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    13698
    Active
    CEPHAPIRIN SODIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13698
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEPHAPIRIN SODIUM
    Issue/Submission Date
    1998-09-01
    ASK
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    your Marketing & Sales content
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    • FDA
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    Imipenem

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

    See Less

    USDMF

    Found USDMF

    21486
    Active
    IMIPENEM AND CILASTATIN (STERILE BU...
    2008-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21486
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IMIPENEM AND CILASTATIN (STERILE BU...
    Issue/Submission Date
    2008-03-31
    ASK
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    Imipenem

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21535
    Active
    IMIPENEM (STERILE BULK)
    2008-04-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21535
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IMIPENEM (STERILE BULK)
    Issue/Submission Date
    2008-04-15
    ASK
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    L-Arginine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22918
    Active
    ARGININE (STERILE BULK)
    2009-06-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22918
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARGININE (STERILE BULK)
    Issue/Submission Date
    2009-06-15
    ASK
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    L-Arginine Hydrochloride API

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19655
    Active
    ARGININE USP, STERILE BULK
    2006-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19655
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ARGININE USP, STERILE BULK
    Issue/Submission Date
    2006-08-03
    ASK
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    • FDA
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    Nafcillin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    13695
    Active
    NAFCILLIN SODIUM FOR INJECTION (BUL...
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13695
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NAFCILLIN SODIUM FOR INJECTION (BUL...
    Issue/Submission Date
    1998-09-01
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    Penicillin G Potassium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15976
    Active
    PENICILLIN G POTASSIUM FOR INJECTIO...
    2002-05-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15976
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENICILLIN G POTASSIUM FOR INJECTIO...
    Issue/Submission Date
    2002-05-10
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    Sodium Bicarbonate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    12585
    Active
    SODIUM BICARBONATE, STERILE
    1997-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12585
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SODIUM BICARBONATE, STERILE
    Issue/Submission Date
    1997-07-09
    ASK
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    • FDA
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    Trisodium Citrate Dihydrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    11809
    Active
    STERILE TRISODIUM CITRATE DIHYDRATE
    1996-01-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11809
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    STERILE TRISODIUM CITRATE DIHYDRATE
    Issue/Submission Date
    1996-01-15
    ASK
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    • FDA
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    DEFU (DECARBAMOYLCEFUROXINE)

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15043
    Active
    DEFU (DECARBAMOYLCEFUROXINE)
    2000-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15043
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEFU (DECARBAMOYLCEFUROXINE)
    Issue/Submission Date
    2000-09-28
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