Details for New Drug Application (NDA): 078319
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NDA 078319 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 078319
| Tradename: | SUMATRIPTAN SUCCINATE |
| Applicant: | Antares Pharma Inc |
| Ingredient: | sumatriptan succinate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | ||||
| Approval Date: | Dec 10, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | ||||
| Approval Date: | Dec 10, 2015 | TE: | RLD: | No | |||||
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