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US Department of Justice
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090641

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NDA 090641 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 Labs Ltd, Par Pharm, Par Sterile Products, Sagent Agila, Sagent Strides, Sandoz Inc, Sun Pharma Global, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Apotex Inc, Aurobindo Pharma, Hikma Pharms, Mylan, Orchid Hlthcare, Roxane, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-two NDAs. It is available from thirty-nine suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE profile page.

The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There are twenty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 090641
Tradename:SUMATRIPTAN SUCCINATE
Applicant:Sagent Agila
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090641
Suppliers and Packaging for NDA: 090641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090641 ANDA Sagent Pharmaceuticals 25021-703 25021-703-70 2 BLISTER PACK in 1 CARTON (25021-703-70) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE
SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090641 ANDA Sagent Pharmaceuticals 25021-703 25021-703-60 5 VIAL in 1 CARTON (25021-703-60) > .5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Jul 28, 2010TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Boehringer Ingelheim
Healthtrust
Daiichi Sankyo
McKinsey
Chubb
QuintilesIMS

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