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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sandoz B2B

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    Sandoz B2B
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    Forum 1, Novartis Campus, CH-4056 Basel
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    +41 613241111
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    13764
    Active
    AMOXCILLIN TRIHYDRATE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 2023-277 - Rev 00
    Valid
    Amoxicillin trihydrate, Powder and ...
    2023-09-18
    Japanese DMF

    Found JDMF

    217MF10761
    Amoxicillin at Ctra. Granollers-Car...
    2005-10-20
    Written Confirmation

    Close WC

    Application Number
    13764
    CEP 2023-277 - Rev 00
    217MF10761
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMOXCILLIN TRIHYDRATE USP
    Amoxicillin trihydrate, Powder and ...
    Amoxicillin at Ctra. Granollers-Car...
    Issue/Submission Date
    1998-09-01
    2023-09-18
    2005-10-20
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    Ampicillin Sodium

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    USDMF

    Found USDMF

    13754
    Active
    AMPICILLIN SODIUM (STERILE)
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 1993-005 - Rev 08
    Valid
    Ampicillin sodium, Sterile
    2024-02-20
    Japanese DMF

    Found JDMF

    217MF10454
    Ampicillin sodium at Biochemiesstra...
    2005-08-24
    Written Confirmation

    Close WC

    Application Number
    13754
    CEP 1993-005 - Rev 08
    217MF10454
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMPICILLIN SODIUM (STERILE)
    Ampicillin sodium, Sterile
    Ampicillin sodium at Biochemiesstra...
    Issue/Submission Date
    1998-09-01
    2024-02-20
    2005-08-24
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    Gentamicin Sulfate

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    USDMF

    Found USDMF

    13704
    Active
    GENTAMICIN SULFATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-121 - Rev 01
    Valid
    Gentamicin sulfate
    2016-02-03
    Japanese DMF

    Found JDMF

    220MF10041
    Gentamicin sulfate at Verovskova ul...
    2008-02-05
    Written Confirmation

    Close WC

    Application Number
    13704
    R1-CEP 2005-121 - Rev 01
    220MF10041
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    GENTAMICIN SULFATE
    Gentamicin sulfate
    Gentamicin sulfate at Verovskova ul...
    Issue/Submission Date
    1998-09-01
    2016-02-03
    2008-02-05
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    Levothyroxine Sodium

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    USDMF

    Found USDMF

    4789
    Active
    LEVOTHYROXINE SODIUM
    1983-01-06
    CEP/COS

    Found CEP/COS

    CEP 1998-141 - Rev 11
    Valid
    Levothyroxine sodium, Code 460 187 ...
    2023-09-26
    Japanese DMF

    Found JDMF

    217MF10456
    Levothyroxine sodium at Biochemiess...
    2005-08-24
    Written Confirmation

    Close WC

    Application Number
    4789
    CEP 1998-141 - Rev 11
    217MF10456
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVOTHYROXINE SODIUM
    Levothyroxine sodium, Code 460 187 ...
    Levothyroxine sodium at Biochemiess...
    Issue/Submission Date
    1983-01-06
    2023-09-26
    2005-08-24
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    Penicillin G Potassium

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    USDMF

    Found USDMF

    13767
    Active
    STERILE PENICILLIN G POTASSIUM BUFF...
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 1999-017 - Rev 05
    Valid
    Benzylpenicillin (procaine) monohyd...
    2023-09-22
    Japanese DMF

    Found JDMF

    229MF10169
    Benzylpenicillin benzathine (1% Lec...
    2017-08-28
    Written Confirmation

    Close WC

    Application Number
    13767
    CEP 1999-017 - Rev 05
    229MF10169
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STERILE PENICILLIN G POTASSIUM BUFF...
    Benzylpenicillin (procaine) monohyd...
    Benzylpenicillin benzathine (1% Lec...
    Issue/Submission Date
    1998-09-01
    2023-09-22
    2017-08-28
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    Cefpodoxime Proxetil

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    USDMF

    Caution USDMF

    16542
    Inactive
    CEFPODOXIME PROXETIL
    2003-04-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-283 - Rev 01
    Valid
    Cefpodoxime proxetil
    2017-12-05
    Japanese DMF

    Found JDMF

    225MF10129
    Cefpodoxime proxetil at Biochemiess...
    2013-07-09
    Written Confirmation

    Close WC

    Application Number
    16542
    R1-CEP 2010-283 - Rev 01
    225MF10129
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFPODOXIME PROXETIL
    Cefpodoxime proxetil
    Cefpodoxime proxetil at Biochemiess...
    Issue/Submission Date
    2003-04-15
    2017-12-05
    2013-07-09
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    Penicillin G Potassium

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    USDMF

    Caution USDMF

    16847
    Inactive
    PENICILLIN G POTASSIUM STERILE AND ...
    2003-09-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-395 - Rev 03
    Valid
    Benzylpenicillin potassium, Sterile
    2019-11-20
    Japanese DMF

    Found JDMF

    231MF10072
    Benzylpenicillin benzatin, 1% lecit...
    2019-03-12
    Written Confirmation

    Close WC

    Application Number
    16847
    R1-CEP 2001-395 - Rev 03
    231MF10072
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PENICILLIN G POTASSIUM STERILE AND ...
    Benzylpenicillin potassium, Sterile
    Benzylpenicillin benzatin, 1% lecit...
    Issue/Submission Date
    2003-09-18
    2019-11-20
    2019-03-12
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    20765
    Active
    ROSUVASTATIN CALCIUM
    2007-08-09
    CEP/COS

    Caution CEP/COS

    R0-CEP 2016-321 - Rev 01
    Withdrawn by Holder
    Rosuvastatin calcium, Process C
    2019-04-15
    Japanese DMF

    Found JDMF

    228MF10155
    Rosuvastatin calcium at Verovskova ...
    2016-08-08
    Written Confirmation

    Close WC

    Application Number
    20765
    R0-CEP 2016-321 - Rev 01
    228MF10155
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium, Process C
    Rosuvastatin calcium at Verovskova ...
    Issue/Submission Date
    2007-08-09
    2019-04-15
    2016-08-08
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    Vancomycin Hydrochloride

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    USDMF

    Caution USDMF

    13223
    Inactive
    VANCOMYCIN HYDROCHLORIDE
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-179 - Rev 03
    Valid
    Vancomycin hydrochloride
    2019-12-18
    Japanese DMF

    Found JDMF

    217MF10740
    Vancomycin Hydrochloride at Verovsk...
    2005-10-07
    Written Confirmation

    Close WC

    Application Number
    13223
    R1-CEP 2004-179 - Rev 03
    217MF10740
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    VANCOMYCIN HYDROCHLORIDE
    Vancomycin hydrochloride
    Vancomycin Hydrochloride at Verovsk...
    Issue/Submission Date
    1998-04-30
    2019-12-18
    2005-10-07
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    Amlodipine Besylate

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    USDMF

    Caution USDMF

    16887
    Inactive
    AMLODIPINE BESYLATE
    2003-10-02
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-210 - Rev 00
    Withdrawn by Holder
    Amlodipine besilate
    2011-07-01
    Japanese DMF

    Found JDMF

    222MF10151
    Amlodipine besylate "FIA" at Verovs...
    2010-05-17
    Written Confirmation

    Close WC

    Application Number
    16887
    R1-CEP 2004-210 - Rev 00
    222MF10151
    Status
    Inactive
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    AMLODIPINE BESYLATE
    Amlodipine besilate
    Amlodipine besylate "FIA" at Verovs...
    Issue/Submission Date
    2003-10-02
    2011-07-01
    2010-05-17
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    Amoxicillin Sodium

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    USDMF

    Found USDMF

    18044
    Active
    AMOXICILLIN SODIUM (NON-STERILE BUL...
    2005-02-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-036 - Rev 09
    Valid
    Amoxicillin sodium, Sterile, proces...
    2022-09-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18044
    R1-CEP 1999-036 - Rev 09
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN SODIUM (NON-STERILE BUL...
    Amoxicillin sodium, Sterile, proces...
    Issue/Submission Date
    2005-02-01
    2022-09-09
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    Amoxicillin Trihydrate

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    USDMF

    Found USDMF

    38086
    Active
    AMOXICILLIN TRIHYDRATE
    2023-06-02
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-034 - Rev 06
    Valid
    Amoxicillin trihydrate, Material co...
    2015-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38086
    R2-CEP 1995-034 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMOXICILLIN TRIHYDRATE
    Amoxicillin trihydrate, Material co...
    Issue/Submission Date
    2023-06-02
    2015-11-12
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    Ampicillin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13212
    Active
    AMPICILLIN ANHYDROUS
    1998-04-30
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-188 - Rev 03
    Valid
    Ampicillin, Powder, compacted
    2018-01-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13212
    R1-CEP 1999-188 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMPICILLIN ANHYDROUS
    Ampicillin, Powder, compacted
    Issue/Submission Date
    1998-04-30
    2018-01-15
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    13765
    Active
    AMPICILLIN TRIHYDRATE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-035 - Rev 05
    Valid
    Ampicillin trihydrate, Powder and c...
    2020-02-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13765
    R2-CEP 1995-035 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMPICILLIN TRIHYDRATE
    Ampicillin trihydrate, Powder and c...
    Issue/Submission Date
    1998-09-01
    2020-02-17
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    Atorvastatin

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    USDMF

    Found USDMF

    18082
    Active
    ATORVASTATIN CALCIUM
    2005-02-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10232
    Atorvastatin calcium hydrate at Ver...
    2010-09-24
    Written Confirmation

    Close WC

    Application Number
    18082
    222MF10232
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium hydrate at Ver...
    Issue/Submission Date
    2005-02-01
    2010-09-24
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    Azithromycin

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    USDMF

    Caution USDMF

    16390
    Inactive
    AZITHROMYCIN MONOHYDRATE (NON-STERI...
    2003-01-30
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-257 - Rev 01
    Withdrawn by Holder
    Azithromycin, Monohydrate
    2012-09-26
    Japanese DMF

    Found JDMF

    224MF10040
    Azithromycin hydrate at Ctra. Grano...
    2012-02-28
    Written Confirmation

    Close WC

    Application Number
    16390
    R1-CEP 2002-257 - Rev 01
    224MF10040
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    AZITHROMYCIN MONOHYDRATE (NON-STERI...
    Azithromycin, Monohydrate
    Azithromycin hydrate at Ctra. Grano...
    Issue/Submission Date
    2003-01-30
    2012-09-26
    2012-02-28
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    Benzathine Benzylpenicilline

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    USDMF

    Found USDMF

    13294
    Active
    PENICILLIN G BENZATHINE (STERILE)
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-066 - Rev 05
    Valid
    Benzylpenicillin (benzathine) tetra...
    2023-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13294
    R1-CEP 2001-066 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PENICILLIN G BENZATHINE (STERILE)
    Benzylpenicillin (benzathine) tetra...
    Issue/Submission Date
    1998-09-01
    2023-07-26
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    Benzylpenicillin Sodium

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    USDMF

    Found USDMF

    13751
    Active
    PENICILLIN G SODIUM (STERILE)
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 1992-017 - Rev 08
    Valid
    Benzylpenicillin sodium, Sterile
    2023-09-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13751
    CEP 1992-017 - Rev 08
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PENICILLIN G SODIUM (STERILE)
    Benzylpenicillin sodium, Sterile
    Issue/Submission Date
    1998-09-01
    2023-09-27
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    Bromocriptine Mesylate

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    USDMF

    Found USDMF

    6827
    Active
    BROMOCRIPTINE MESYLATE USP
    1987-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10054
    Bromocriptine mesylate at Verovskov...
    2009-03-16
    Written Confirmation

    Close WC

    Application Number
    6827
    221MF10054
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BROMOCRIPTINE MESYLATE USP
    Bromocriptine mesylate at Verovskov...
    Issue/Submission Date
    1987-02-13
    2009-03-16
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    Cefazolin Sodium

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    USDMF

    Found USDMF

    14133
    Active
    CEFAZOLIN SODIUM (STERILE)
    1999-05-03
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-074 - Rev 09
    Valid
    Cefazolin sodium, Sterile
    2016-07-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14133
    R1-CEP 1999-074 - Rev 09
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFAZOLIN SODIUM (STERILE)
    Cefazolin sodium, Sterile
    Issue/Submission Date
    1999-05-03
    2016-07-28
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    Ceftazidime

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    USDMF

    Found USDMF

    7115
    Active
    CTAZ-TBE (CEFTAZIDIME-TERT-BUTYLEST...
    1987-08-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-252 - Rev 04
    Valid
    Ceftazidime Pentahydrate, Sterile
    2015-06-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7115
    R1-CEP 2001-252 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CTAZ-TBE (CEFTAZIDIME-TERT-BUTYLEST...
    Ceftazidime Pentahydrate, Sterile
    Issue/Submission Date
    1987-08-24
    2015-06-15
    ASK
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    Ceftazidime

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13009
    Active
    CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORI...
    1998-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-272 - Rev 01
    Valid
    Ceftazidime pentahydrate with sodiu...
    2019-05-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13009
    R1-CEP 2010-272 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORI...
    Ceftazidime pentahydrate with sodiu...
    Issue/Submission Date
    1998-05-25
    2019-05-03
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    Ceftriaxone

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    USDMF

    Found USDMF

    4996
    Active
    7-ACT
    1983-06-21
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-192 - Rev 05
    Valid
    Ceftriaxone sodium, Sterile
    2018-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4996
    R1-CEP 1999-192 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    7-ACT
    Ceftriaxone sodium, Sterile
    Issue/Submission Date
    1983-06-21
    2018-02-16
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    Ceftriaxone

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    USDMF

    Found USDMF

    16467
    Active
    CEFTRIAXONE SODIUM (STERILE)
    2003-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-137 - Rev 04
    Valid
    Ceftriaxone sodium, Sterile
    2016-09-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16467
    R1-CEP 2004-137 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFTRIAXONE SODIUM (STERILE)
    Ceftriaxone sodium, Sterile
    Issue/Submission Date
    2003-03-12
    2016-09-02
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    Clavulanic Acid

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    USDMF

    Found USDMF

    14679
    Active
    CLAVULANATE POTASSIUM
    2000-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-142 - Rev 09
    Valid
    Potassium clavulanate, Sterile
    2021-03-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14679
    R1-CEP 1998-142 - Rev 09
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM
    Potassium clavulanate, Sterile
    Issue/Submission Date
    2000-01-19
    2021-03-10
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    Clavulanic Acid

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    USDMF

    Found USDMF

    15211
    Active
    CLAVULANATE POTASSIUM
    2000-12-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-262 - Rev 03
    Valid
    Potassium clavulanate
    2020-06-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15211
    R1-CEP 2003-262 - Rev 03
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM
    Potassium clavulanate
    Issue/Submission Date
    2000-12-26
    2020-06-17
    ASK
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    Clavulanic Acid

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    USDMF

    Found USDMF

    32777
    Active
    CLAVULANATE POTASSIUM DILUTED WITH ...
    2018-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-241 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2020-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32777
    R1-CEP 2004-241 - Rev 03
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    CLAVULANATE POTASSIUM DILUTED WITH ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2018-05-17
    2020-02-07
    ASK
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    Clavulanic Acid

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    USDMF

    Found USDMF

    36941
    Active
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2023-01-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-242 - Rev 03
    Valid
    Potassium clavulanate, diluted, wit...
    2020-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36941
    R1-CEP 2004-242 - Rev 03
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2023-01-17
    2020-02-07
    ASK
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    Clavulanic Acid

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    USDMF

    Found USDMF

    37008
    Active
    POTASSIUM CLAVULANATE DILUTED WITH ...
    2023-09-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-001 - Rev 09
    Valid
    Potassium clavulanate, Code Number ...
    2020-02-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37008
    R1-CEP 1998-001 - Rev 09
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    POTASSIUM CLAVULANATE DILUTED WITH ...
    Potassium clavulanate, Code Number ...
    Issue/Submission Date
    2023-09-27
    2020-02-25
    ASK
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    Cloxacillin Sodium

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    USDMF

    Found USDMF

    13795
    Active
    CLOXACILLIN SODIUM (NON-STERILE, BU...
    1998-09-01
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-036 - Rev 05
    Valid
    Cloxacillin sodium, Powder, Compact...
    2019-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13795
    R2-CEP 1995-036 - Rev 05
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLOXACILLIN SODIUM (NON-STERILE, BU...
    Cloxacillin sodium, Powder, Compact...
    Issue/Submission Date
    1998-09-01
    2019-11-18
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    Penicillin G Procaine

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    USDMF

    Found USDMF

    13575
    Active
    STERILE PENICILLIN G PROCAINE
    1998-09-01
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-003 - Rev 04
    Valid
    Benzylpenicillin (procaine) monohyd...
    2019-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13575
    R2-CEP 1995-003 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STERILE PENICILLIN G PROCAINE
    Benzylpenicillin (procaine) monohyd...
    Issue/Submission Date
    1998-09-01
    2019-12-05
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    Penicillin V Potassium

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    USDMF

    Found USDMF

    13295
    Active
    PENICILLIN V POTASSIUM
    1998-09-01
    CEP/COS

    Found CEP/COS

    R2-CEP 1994-012 - Rev 06
    Valid
    Phenoxymethylpenicillin potassium, ...
    2017-05-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13295
    R2-CEP 1994-012 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PENICILLIN V POTASSIUM
    Phenoxymethylpenicillin potassium, ...
    Issue/Submission Date
    1998-09-01
    2017-05-15
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    Tacrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19979
    Active
    TACROLIMUS
    2006-11-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-204 - Rev 01
    Valid
    Tacrolimus monohydrate
    2023-08-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19979
    R0-CEP 2021-204 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    TACROLIMUS
    Tacrolimus monohydrate
    Issue/Submission Date
    2006-11-20
    2023-08-07
    ASK
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    Candesartan Cilexetil

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    USDMF

    Caution USDMF

    20053
    Inactive
    CANDESARTAN CILEXETIL
    2006-12-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10145
    Candesartan cilexetil at Verovskova...
    2013-07-25
    Written Confirmation

    Close WC

    Application Number
    20053
    225MF10145
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CANDESARTAN CILEXETIL
    Candesartan cilexetil at Verovskova...
    Issue/Submission Date
    2006-12-18
    2013-07-25
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    Cefixime

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27527
    Active
    CEFIXIME
    2013-09-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-449 - Rev 00
    Withdrawn by Holder
    Cefixime
    2008-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27527
    R1-CEP 2001-449 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    CEFIXIME
    Cefixime
    Issue/Submission Date
    2013-09-27
    2008-05-14
    ASK
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    Cefixime

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    16313
    Inactive
    CEFIXIME
    2002-12-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-347 - Rev 02
    Valid
    Cefixime
    2018-10-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16313
    R1-CEP 2009-347 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFIXIME
    Cefixime
    Issue/Submission Date
    2002-12-17
    2018-10-31
    ASK
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    Cefotaxime

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    USDMF

    Found USDMF

    21202
    Active
    CEFOTAXIME SODIUM STERILE
    2007-12-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-148 - Rev 03
    Withdrawn by Holder
    Cefotaxime sodium, Sterile
    2018-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21202
    R1-CEP 2002-148 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CEFOTAXIME SODIUM STERILE
    Cefotaxime sodium, Sterile
    Issue/Submission Date
    2007-12-27
    2018-02-15
    ASK
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    Cefpodoxime Proxetil

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    USDMF

    Found USDMF

    20076
    Active
    CEFPODOXIME PROXETIL
    2006-12-26
    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-064 - Rev 00
    Withdrawn by Holder
    Cefpodoxime proxetil, Turbhe site
    2013-09-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20076
    R0-CEP 2013-064 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CEFPODOXIME PROXETIL
    Cefpodoxime proxetil, Turbhe site
    Issue/Submission Date
    2006-12-26
    2013-09-30
    ASK
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    Clavulanic Acid

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    29292
    Active
    CLAVULANATE POTASSIUM DILUTED WITH ...
    2015-08-20
    CEP/COS

    Caution CEP/COS

    R0-CEP 2004-234 - Rev 01
    Expired
    Potassium clavulanate, diluted, wit...
    2009-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29292
    R0-CEP 2004-234 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    CLAVULANATE POTASSIUM DILUTED WITH ...
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2015-08-20
    2009-10-13
    ASK
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    Lithium Carbonate

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    USDMF

    Caution USDMF

    4293
    Inactive
    LITHIUM CARBONATE
    1981-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10493
    Lithium carbonate at Verovskova uli...
    2005-09-06
    Written Confirmation

    Close WC

    Application Number
    4293
    217MF10493
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    LITHIUM CARBONATE
    Lithium carbonate at Verovskova uli...
    Issue/Submission Date
    1981-09-29
    2005-09-06
    ASK
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    Mycophenolate Mofetil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25323
    Active
    MYCOPHENOLATE MOFETIL (PROCESS B), ...
    2011-09-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-222 - Rev 02
    Withdrawn by Holder
    Mycophenolate mofetil
    2016-10-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25323
    R1-CEP 2005-222 - Rev 02
    Status
    Active
    Fees Unpaid
    N/A
    Withdrawn by Holder
     
    Filing Details
    MYCOPHENOLATE MOFETIL (PROCESS B), ...
    Mycophenolate mofetil
    Issue/Submission Date
    2011-09-27
    2016-10-13
    ASK
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    Mycophenolate Mofetil

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    USDMF

    Caution USDMF

    18936
    Inactive
    MYCOPHENOLATE MOFETIL
    2005-11-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-317 - Rev 05
    Valid
    Mycophenolate mofetil, Process B
    2023-08-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18936
    R1-CEP 2011-317 - Rev 05
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    MYCOPHENOLATE MOFETIL
    Mycophenolate mofetil, Process B
    Issue/Submission Date
    2005-11-07
    2023-08-07
    ASK
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    Omeprazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17126
    Inactive
    OMEPRAZOLE
    2004-01-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-025 - Rev 04
    Valid
    Omeprazole
    2018-06-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17126
    R1-CEP 2004-025 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OMEPRAZOLE
    Omeprazole
    Issue/Submission Date
    2004-01-12
    2018-06-04
    ASK
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    Sodium Dicloxacillin

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    USDMF

    Caution USDMF

    13798
    Inactive
    DICLOXACILLIN SODIUM
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-023 - Rev 04
    Valid
    Dicloxacillin sodium, Powder and co...
    2016-07-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13798
    R1-CEP 1996-023 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DICLOXACILLIN SODIUM
    Dicloxacillin sodium, Powder and co...
    Issue/Submission Date
    1998-09-01
    2016-07-25
    ASK
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    • FDA
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    Ceftazidime

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

    See Less

    USDMF

    Found USDMF

    16082
    Active
    CEFTAZIDIME FOR INJECTION
    2002-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16082
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CEFTAZIDIME FOR INJECTION
    Issue/Submission Date
    2002-08-06
    ASK
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    Immunomycin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15113
    Active
    ASCOMYCIN
    2000-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15113
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ASCOMYCIN
    Issue/Submission Date
    2000-10-30
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    Lithium Carbonate

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    USDMF

    Found USDMF

    15677
    Active
    LITHIUM CARBONATE ACTIVE SUBSTANCE
    2001-10-18
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15677
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LITHIUM CARBONATE ACTIVE SUBSTANCE
    Issue/Submission Date
    2001-10-18
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    Mycophenolic Acid

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    USDMF

    Found USDMF

    15824
    Active
    MYCOPHENOLIC ACID
    2002-01-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15824
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MYCOPHENOLIC ACID
    Issue/Submission Date
    2002-01-24
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    PACA

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    USDMF

    Found USDMF

    10838
    Active
    7-PACA (7-AMINO-3-PROPENYL-CEPHALOS...
    1994-03-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    10838
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    7-PACA (7-AMINO-3-PROPENYL-CEPHALOS...
    Issue/Submission Date
    1994-03-29
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    Sirolimus

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    USDMF

    Found USDMF

    15720
    Active
    RAPAMYCIN
    2001-11-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

    Close WC

    Application Number
    15720
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RAPAMYCIN
    Issue/Submission Date
    2001-11-13
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