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Details for New Drug Application (NDA): 090358

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NDA 090358 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Teva Pharms Usa, Injectalia, Sagent Strides, Teva Parenteral, Antares Pharma Inc, Mylan Labs Ltd, Eurohlth Intl Sarl, Aurobindo Pharma, Par Pharm, Watson Labs, Fresenius Kabi Usa, Teva, Sagent Agila, Roxane, Mylan, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Sandoz, Par Sterile Products, Hikma Farmaceutica, Orchid Hlthcare, Wockhardt, Sun Pharm Inds, and Hikma Pharms, and is included in thirty-two NDAs. It is available from thirty-seven 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. There are four tentative approvals for this compound. Additional details are available on the sumatriptan succinate profile page.

Summary for NDA: 090358

Tradename:
SUMATRIPTAN SUCCINATE
Applicant:
Sun Pharma Global
Ingredient:
sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090358

Suppliers and Packaging for NDA: 090358

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 090358 ANDA Sun Pharma Global FZE 47335-276 47335-276-40 1 SYRINGE in 1 PACKAGE (47335-276-40) > .5 mL in 1 SYRINGE
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS 090358 ANDA Sun Pharma Global FZE 47335-276 47335-276-41 2 SYRINGE in 1 PACKAGE (47335-276-41) > .5 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date:Jun 21, 2011TE:ABRLD:No


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