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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Moodys
Chinese Patent Office
US Army
Express Scripts
Harvard Business School
Covington
McKesson

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078284

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NDA 078284 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Injectalia, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Apotex Inc, Aurobindo Pharma, Fosun Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-two NDAs. It is available from thirty-eight suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE profile page.

The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 078284
Tradename:SUMATRIPTAN SUCCINATE
Applicant:Orchid Hlthcare
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078284
Suppliers and Packaging for NDA: 078284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078284 ANDA Northstar Rx LLC 16714-531 N 16714-531-11
SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078284 ANDA Northstar Rx LLC 16714-532 N 16714-532-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 10, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Baxter
Teva
AstraZeneca
Chinese Patent Office
Citi
Daiichi Sankyo
Healthtrust
Harvard Business School

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