Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209718
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription AB No No
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/2018 ORIG-1 Approval STANDARD

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CLOBAZAM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 212398 ACCORD HLTHCARE
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 212714 ALKEM LABS LTD
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209718 AMNEAL PHARMS CO
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 208825 BIONPHARMA INC
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209308 BRECKENRIDGE
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209795 HETERO LABS LTD III
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 208785 HIKMA
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 212092 LANNETT CO INC
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 210545 LUPIN LTD
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 211711 MICRO LABS
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209808 PIRAMAL HLTHCARE UK
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 209687 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 10MG TABLET;ORAL Prescription No AB 211449 ZYDUS PHARMS
ONFI CLOBAZAM 10MG TABLET;ORAL Prescription Yes AB 202067 LUNDBECK PHARMS LLC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 212398 ACCORD HLTHCARE
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 212714 ALKEM LABS LTD
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209718 AMNEAL PHARMS CO
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 208825 BIONPHARMA INC
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209308 BRECKENRIDGE
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209795 HETERO LABS LTD III
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 208785 HIKMA
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 212092 LANNETT CO INC
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 210545 LUPIN LTD
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 211711 MICRO LABS
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209808 PIRAMAL HLTHCARE UK
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 209687 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 20MG TABLET;ORAL Prescription No AB 211449 ZYDUS PHARMS
ONFI CLOBAZAM 20MG TABLET;ORAL Prescription Yes AB 202067 LUNDBECK PHARMS LLC

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