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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Army
Cipla
Dow
Fuji
Argus Health
UBS
Farmers Insurance
Chubb

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078593

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NDA 078593 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 078593
Tradename:SUMATRIPTAN SUCCINATE
Applicant:Wockhardt
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078593
Suppliers and Packaging for NDA: 078593
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078593 ANDA Wockhardt Limited 55648-728 N 55648-728-01
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078593 ANDA Wockhardt USA LLC. 64679-728 N 64679-728-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Feb 6, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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US Department of Justice
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Covington
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