Details for New Drug Application (NDA): 078593
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The generic ingredient in SUMATRIPTAN SUCCINATE is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 078593
Tradename: | SUMATRIPTAN SUCCINATE |
Applicant: | Wockhardt |
Ingredient: | sumatriptan succinate |
Patents: | 0 |
Pharmacology for NDA: 078593
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 078593
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 078593 | ANDA | Wockhardt USA LLC. | 64679-728 | 64679-728-01 | 5 VIAL in 1 CARTON (64679-728-01) / .5 mL in 1 VIAL (64679-728-08) |
SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 078593 | ANDA | Proficient Rx LP | 71205-111 | 71205-111-01 | 1 mL in 1 VIAL (71205-111-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | ||||
Approval Date: | Feb 6, 2009 | TE: | AP | RLD: | No |
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