Details for New Drug Application (NDA): 213518
NDA 213518 describes SUMATRIPTAN SUCCINATE (AUTOINJECTOR), which is a drug marketed by Alembic, Antares Pharma Inc, Dr Reddys, Onesource Specialty, and Sun Pharm, and is included in five NDAs. It is available from ten suppliers. Additional details are available on the SUMATRIPTAN SUCCINATE (AUTOINJECTOR) profile page.
The generic ingredient in SUMATRIPTAN SUCCINATE (AUTOINJECTOR) 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 (AUTOINJECTOR) 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 213518
| Tradename: | SUMATRIPTAN SUCCINATE (AUTOINJECTOR) |
| 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 (AUTOINJECTOR) | sumatriptan succinate | SOLUTION;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 (AUTOINJECTOR) | sumatriptan succinate | SOLUTION;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: | SOLUTION;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: | SOLUTION;SUBCUTANEOUS | Strength | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | ||||
| Approval Date: | Nov 6, 2025 | TE: | AB | RLD: | No | ||||
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