An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215939
Company: ANNORA PHARMA

Products on ANDA 215939

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 215939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215939

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	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	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	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

Top