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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078069
Company: BRECKENRIDGE PHARM

Healthcare Professional Sheet

Products on ANDA 078069

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078069

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
08/08/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/28/2020	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/28/2020	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2015	SUPPL-9	Labeling-Medication Guide, Labeling-Container/Carton Labels		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-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
12/29/2011	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/30/2011	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/29/2010	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078069

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
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
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	077747	RUBICON
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON
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
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
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	077747	RUBICON
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON
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
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	215939	ANNORA PHARMA
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	077747	RUBICON
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	No	AB	207717	RUBICON
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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