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Details for New Drug Application (NDA): 021006

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NDA 021006 describes FROVA, which is a drug marketed by Endo Pharms, Glenmark Pharms Ltd, and Mylan Pharms Inc, and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Seven suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.

Summary for NDA: 021006

Tradename:
FROVA
Applicant:
Endo Pharms
Ingredient:
frovatriptan succinate
Patents:2
Therapeutic Class:Antimigraine Agents
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 Qualitest Pharmaceuticals 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 STAT RX USA LLC 16590-396 16590-396-09 9 TABLET, FILM COATED in 1 BLISTER PACK (16590-396-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Nov 8, 2001TE:ABRLD:Yes
Patent:5,464,864Patent Expiration:Nov 7, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
Patent:5,827,871Patent Expiration:Oct 27, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS

Expired Orange Book Patents for NDA: 021006

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,917,054► subscribe
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,962,501► subscribe
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,464,864► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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