Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217659
Company: AJANTA PHARMA LTD

Products on ANDA 217659

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217659

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217659

OXCARBAZEPINE

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	217659	AJANTA PHARMA LTD
OXTELLAR XR	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202810	SUPERNUS PHARMS

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	217659	AJANTA PHARMA LTD
OXTELLAR XR	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202810	SUPERNUS PHARMS

TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL	Prescription	No	AB	217659	AJANTA PHARMA LTD
OXTELLAR XR	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	202810	SUPERNUS PHARMS