Details for New Drug Application (NDA): 078295
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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 078295
Tradename: | SUMATRIPTAN SUCCINATE |
Applicant: | Sun Pharm Inds |
Ingredient: | sumatriptan succinate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078295
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 078295
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078295 | ANDA | A-S Medication Solutions | 50090-5939 | 50090-5939-0 | 9 BLISTER PACK in 1 CARTON (50090-5939-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078295 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-520 | 62756-520-01 | 3 BLISTER PACK in 1 CARTON (62756-520-01) / 9 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Aug 10, 2009 | TE: | AB | RLD: | No |
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