Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202961
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML 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
09/17/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/04/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

OXCARBAZEPINE

SUSPENSION;ORAL; 300MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 202961 AMNEAL PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 201193 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 078734 SUN PHARM INDS LTD
TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription Yes AB 021285 NOVARTIS

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