Details for New Drug Application (NDA): 021006

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NDA 021006 describes FROVA, which is a drug marketed by Endo Operations, Amneal Pharms Co, Glenmark Pharms Ltd, Norvium Bioscience, and Renata, and is included in five NDAs. It is available from one supplier. Additional details are available on the FROVA profile page.

The generic ingredient in FROVA is frovatriptan succinate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.

Summary for 021006

Tradename:	FROVA
Applicant:	Endo Operations
Ingredient:	frovatriptan succinate
Patents:	0

Pharmacology for NDA: 021006

Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 021006

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FROVA	frovatriptan succinate	TABLET;ORAL	021006	NDA	Endo USA, Inc.	0603-3718	0603-3718-34	1 BLISTER PACK in 1 CARTON (0603-3718-34) / 9 TABLET, FILM COATED in 1 BLISTER PACK
FROVA	frovatriptan succinate	TABLET;ORAL	021006	NDA	Endo USA, Inc.	63481-025	63481-025-09	1 BLISTER PACK in 1 CARTON (63481-025-09) / 9 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Nov 8, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021006

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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