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Last Updated: July 19, 2024

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, Mylan, and Renata, and is included in five NDAs. It is available from two suppliers. 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. Five 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021006
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 Par Pharmaceutical 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 Pharmaceuticals, 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:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Nov 8, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021006

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
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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