Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211292
Company: AMNEAL PHARMS CO

Products on ANDA 211292

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2018	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
05/17/2024	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211292

FROVATRIPTAN SUCCINATE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FROVA	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021006	ENDO OPERATIONS
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	211292	AMNEAL PHARMS CO
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	204730	GLENMARK PHARMS LTD
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET;ORAL	Prescription	No	AB	213891	RENATA