Application 078319
- Type
- ANDA
- Sponsor
- ANTARES PHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | INJECTABLE;SUBCUTANEOUS | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | No | No |
| 002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | INJECTABLE;SUBCUTANEOUS | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-2013 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2013 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2013 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2013 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2013 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2014 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2014 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2014 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2014 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 0093-2014 | Sumatriptan | sumatriptan succinate | Teva Pharmaceuticals USA Inc | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-994 | Sumatriptan | sumatriptan succinate | Golden State Medical Supply, Inc. | ANDA | Current |