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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Accenture
Farmers Insurance
Chubb
US Army
Moodys
Fish and Richardson
Chinese Patent Office
Cerilliant

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078319

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NDA 078319 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 078319
Tradename:SUMATRIPTAN SUCCINATE
Applicant:Antares Pharma Inc
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078319
Suppliers and Packaging for NDA: 078319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078319 ANDA Teva Pharmaceuticals USA Inc 0093-2013 N 0093-2013-12
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078319 ANDA Teva Pharmaceuticals USA Inc 0093-2014 N 0093-2014-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date:Dec 10, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Dec 10, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Colorcon
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Julphar
Medtronic
Healthtrust
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