Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217795
Company: ALKEM LABS LTD

Products on ANDA 217795

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2025	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 217795

TOPIRAMATE

SOLUTION;ORAL; 25MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPRONTIA	TOPIRAMATE	25MG/ML	SOLUTION;ORAL	Prescription	Yes	AB	214679	AZURITY
TOPIRAMATE	TOPIRAMATE	25MG/ML	SOLUTION;ORAL	Prescription	No	AB	217795	ALKEM LABS LTD