Details for New Drug Application (NDA): 213518
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NDA 213518 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Alembic, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Onesource Specialty, Ph Health, Sandoz, Sun Pharm, 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, and Zhejiang, and is included in thirty-eight NDAs. It is available from thirty-three 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-eight 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 are twenty-four drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 213518
| Tradename: | SUMATRIPTAN SUCCINATE |
| Applicant: | Alembic |
| Ingredient: | sumatriptan succinate |
| Patents: | 0 |
Pharmacology for NDA: 213518
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 213518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 213518 | ANDA | Alembic Pharmaceuticals Limited | 46708-656 | 46708-656-01 | 2 SYRINGE in 1 CARTON (46708-656-01) / .5 mL in 1 SYRINGE |
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 213518 | ANDA | Alembic Pharmaceuticals Limited | 46708-656 | 46708-656-05 | 1 SYRINGE in 1 CARTON (46708-656-05) / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | ||||
| Approval Date: | Nov 6, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | ||||
| Approval Date: | Nov 6, 2025 | TE: | AB | RLD: | No | ||||
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