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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076554


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NDA 076554 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Antares Pharma Inc, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz, Somerset, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty 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. Thirty-four suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 076554
Tradename:SUMATRIPTAN SUCCINATE
Applicant:Sun Pharm Inds Ltd
Ingredient:sumatriptan succinate
Patents:0
Formulation / Manufacturing:see details
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 sumatriptan succinate TABLET;ORAL 076554 ANDA Proficient Rx LP 63187-164 63187-164-09 9 TABLET in 1 BLISTER PACK (63187-164-09)
SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076554 ANDA SUN PHARMACEUTICAL INDUSTRIES, INC. 63304-097 63304-097-13 120 TABLET in 1 BOTTLE (63304-097-13)

Profile for product number 001

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

Profile for product number 002

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

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