Details for New Drug Application (NDA): 213998
✉ Email this page to a colleague
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 213998
Tradename: | SUMATRIPTAN SUCCINATE |
Applicant: | Somerset |
Ingredient: | sumatriptan succinate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213998
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 213998
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 213998 | ANDA | Caplin Steriles Limited | 65145-118 | 65145-118-05 | 5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01) |
SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 213998 | ANDA | Somerset Therapeutics, LLC | 70069-804 | 70069-804-01 | 1 VIAL in 1 CARTON (70069-804-01) / .5 mL in 1 VIAL |
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: | Jul 13, 2021 | TE: | AP | RLD: | No |
Complete Access Available with Subscription