Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210039
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;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

Label is not available on this site.

CLOBAZAM

SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210039 AMNEAL PHARMS LLC
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 208819 BIONPHARMA INC
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 209715 HIKMA
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210546 LUPIN LTD
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 211259 MYLAN
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210569 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210746 VISTAPHARM
ONFI CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription Yes AB 203993 LUNDBECK PHARMS LLC

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