Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215449
Company: AUROBINDO PHARMA LTD

Products on ANDA 215449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	AB	No	No
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215449

TOPIRAMATE

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	Yes	AB	020844	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	No	AB	215449	AUROBINDO PHARMA LTD
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	No	AB	078418	STRIDES PHARMA
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	No	AB	076575	TEVA
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	No	AB	217694	TWI PHARMS
TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE;ORAL	Prescription	No	AB	078877	ZYDUS PHARMS USA INC

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOPAMAX	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	Yes	AB	020844	JANSSEN PHARMS
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	No	AB	215449	AUROBINDO PHARMA LTD
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	No	AB	078418	STRIDES PHARMA
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	No	AB	076575	TEVA
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	No	AB	217694	TWI PHARMS
TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE;ORAL	Prescription	No	AB	078877	ZYDUS PHARMS USA INC