BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Cantor Fitzgerald

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200502

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NDA 200502 describes NARATRIPTAN, which is a drug marketed by Apotex Corp, Heritage Pharms Inc, Mylan Pharms Inc, Orchid Hlthcare, Paddock Llc, Sandoz, 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 200502
Applicant:Heritage Pharms Inc
Ingredient:naratriptan hydrochloride
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200502
Suppliers and Packaging for NDA: 200502
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 200502 ANDA Heritage Pharmaceuticals Inc. 23155-054 23155-054-03 30 TABLET in 1 BOTTLE (23155-054-03)
NARATRIPTAN naratriptan hydrochloride TABLET;ORAL 200502 ANDA Heritage Pharmaceuticals Inc. 23155-054 23155-054-19 9 TABLET in 1 BLISTER PACK (23155-054-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 28, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Feb 28, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Harvard Business School
US Department of Justice
Argus Health

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