Details for New Drug Application (NDA): 078327
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NDA 078327 describes SUMATRIPTAN SUCCINATE, which is a drug marketed by Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience Speclts, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty 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-five 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-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.
Summary for 078327
| Tradename: | SUMATRIPTAN SUCCINATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | sumatriptan succinate |
| Patents: | 0 |
Pharmacology for NDA: 078327
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 078327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078327 | ANDA | NorthStar Rx LLC | 16714-796 | 16714-796-01 | 1 BLISTER PACK in 1 CARTON (16714-796-01) / 9 TABLET in 1 BLISTER PACK |
| SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078327 | ANDA | NorthStar Rx LLC | 16714-797 | 16714-797-01 | 1 BLISTER PACK in 1 CARTON (16714-797-01) / 9 TABLET 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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