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Novartis
Federal Trade Commission
Argus Health
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US Department of Justice
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091326

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NDA 091326 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 six 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. Seven suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.

Summary for NDA: 091326

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091326

Suppliers and Packaging for NDA: 091326

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NARATRIPTAN
naratriptan hydrochloride
TABLET;ORAL 091326 ANDA Paddock Laboratories, LLC 0574-0214 0574-0214-09 9 BLISTER PACK in 1 CARTON (0574-0214-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK
NARATRIPTAN
naratriptan hydrochloride
TABLET;ORAL 091326 ANDA Paddock Laboratories, LLC 0574-0215 0574-0215-09 9 BLISTER PACK in 1 CARTON (0574-0215-09) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jul 8, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 8, 2010TE:ABRLD:No


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