Details for New Drug Application (NDA): 207101
NDA 207101 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Baxter Hlthcare Corp, Caplin, Eugia Pharma, Fresenius Kabi Usa, Hikma, Onesource Specialty, Ph Health, Pharmobedient, Sandoz, Teva Parenteral, Teva Pharms Usa, Wockhardt Bio Ag, Zydus, Aurobindo Pharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Ipca Labs Ltd, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Vkt Pharma, Watson Labs, Zhejiang, Alembic, Antares Pharma Inc, Dr Reddys, and Sun Pharm, and is included in thirty-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE profile page.
The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There is one drug master file entry for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There is one drug master file entry for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 207101
| Tradename: | SUMATRIPTAN SUCCINATE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | sumatriptan succinate |
| Patents: | 0 |
Pharmacology for NDA: 207101
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 207101
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | SOLUTION;SUBCUTANEOUS | 207101 | ANDA | Baxter Healthcare Corporation | 36000-289 | 36000-289-05 | 5 VIAL in 1 CARTON (36000-289-05) / .5 mL in 1 VIAL |
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | SOLUTION;SUBCUTANEOUS | 207101 | ANDA | Baxter Healthcare Corporation | 36000-289 | 36000-289-10 | 10 VIAL in 1 CARTON (36000-289-10) / .5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | ||||
| Approval Date: | Jan 19, 2023 | TE: | RLD: | No | |||||
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