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Generated: September 22, 2018

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Details for New Drug Application (NDA): 204730

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NDA 204730 describes FROVATRIPTAN SUCCINATE, which is a drug marketed by Glenmark Pharms Ltd and Mylan Pharms Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the FROVATRIPTAN SUCCINATE profile page.

The generic ingredient in FROVATRIPTAN SUCCINATE 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 204730
Applicant:Glenmark Pharms Ltd
Ingredient:frovatriptan succinate
Formulation / Manufacturing:see details
Pharmacology for NDA: 204730
Suppliers and Packaging for NDA: 204730
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 204730 ANDA Glenmark Pharmaceuticals Inc., USA 68462-694 68462-694-97 1 BLISTER PACK in 1 CARTON (68462-694-97) > 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:Mar 11, 2016TE:ABRLD:No

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