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Generated: May 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090288

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NDA 090288 describes NARATRIPTAN, which is a drug marketed by Heritage Pharms Inc, Paddock Llc, Mylan Pharms Inc, Orchid Hlthcare, Teva Pharms, Sun Pharm Inds Ltd, Apotex Corp, West-ward Pharms Int, and Sandoz, and is included in nine NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for NDA: 090288

Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090288

Suppliers and Packaging for NDA: 090288

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naratriptan hydrochloride
TABLET;ORAL 090288 ANDA Sandoz Inc 0781-5526 0781-5526-37 1 BLISTER PACK in 1 CARTON (0781-5526-37) > 9 TABLET, COATED in 1 BLISTER PACK
naratriptan hydrochloride
TABLET;ORAL 090288 ANDA Sandoz Inc 0781-5527 0781-5527-37 1 BLISTER PACK in 1 CARTON (0781-5527-37) > 9 TABLET, COATED in 1 BLISTER PACK

Summary for product number 001

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

Summary 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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