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Generated: November 16, 2018

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Details for New Drug Application (NDA): 090381

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NDA 090381 describes NARATRIPTAN, which is a drug marketed by Apotex Corp, Casi Pharms Inc, Heritage Pharms Inc, Mylan Pharms Inc, Orchid Hlthcare, Paddock Llc, Sun Pharm Inds Ltd, Teva Pharms, and West-ward Pharms Int, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the NARATRIPTAN profile page.

The generic ingredient in NARATRIPTAN is naratriptan hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for 090381
Tradename:NARATRIPTAN
Applicant:West-ward Pharms Int
Ingredient:naratriptan hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090381
Suppliers and Packaging for NDA: 090381
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090381 ANDA West-Ward Pharmaceuticals Corp. 0054-0278 0054-0278-03 9 TABLET in 1 BOTTLE (0054-0278-03)
NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 090381 ANDA West-Ward Pharmaceuticals Corp. 0054-0279 0054-0279-03 9 TABLET in 1 BOTTLE (0054-0279-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jul 7, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 7, 2010TE:ABRLD:No

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