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Details for New Drug Application (NDA): 076554

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NDA 076554 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-six 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-six 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: 076554

Sun Pharm Inds Ltd
sumatriptan succinate

Pharmacology for NDA: 076554

Suppliers and Packaging for NDA: 076554

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sumatriptan succinate
TABLET;ORAL 076554 ANDA REMEDYREPACK INC. 49349-889 49349-889-51 9 TABLET in 1 VIAL (49349-889-51)
sumatriptan succinate
TABLET;ORAL 076554 ANDA A-S Medication Solutions 50090-1764 50090-1764-0 1 BLISTER PACK in 1 CARTON (50090-1764-0) > 9 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

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