Application 078593
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-728 | Sumatriptan Succinate | Sumatriptan Succinate | Wockhardt Limited | ANDA | Current |
| 64679-728 | Sumatriptan Succinate | Sumatriptan Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-728 | Sumatriptan Succinate | Sumatriptan Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-728 | Sumatriptan Succinate | Sumatriptan Succinate | Wockhardt USA LLC. | ANDA | Current |
| 71205-111 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 71205-111 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 39562 | ORIG | 2009-02-06 |