Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078069
Company: BRECKENRIDGE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription AB No No
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription AB No No
OXCARBAZEPINE OXCARBAZEPINE 600MG 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
01/11/2008 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/078069_bioeq_rev-oxcarbazepine tabs.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2015 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

12/03/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

12/29/2011 SUPPL-3 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

08/30/2011 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

06/29/2010 SUPPL-1 Labeling

Label is not available on this site.

OXCARBAZEPINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077795 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 150MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077795 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 300MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 078005 ANI PHARMS INC
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077747 APOTEX INC
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077795 HIKMA
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 600MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

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