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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201193
Company: HIKMA
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
10/03/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/28/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/24/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

07/24/2015 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 211420 AKORN
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 202961 AMNEAL PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 215332 AUCTA
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 209652 BIONPHARMA INC
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 212428 GLASSHOUSE PHARMS
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 201193 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION;ORAL Prescription No AB 215726 RUBICON
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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