Application 021006
- Type
- NDA
- Sponsor
- ENDO PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FROVA | FROVATRIPTAN SUCCINATE | TABLET;ORAL | EQ 2.5MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0603-3718 | Frovatriptan Succinate | frovatriptan succinate | Par Pharmaceutical | NDA | Current |
| 50436-0026 | FROVA | frovatriptan succinate | Unit Dose Services | NDA | Current |
| 63481-025 | FROVA | frovatriptan succinate | Endo Pharmaceuticals, Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 55326 | SUPPL | 2018-08-27 |
| 55254 | SUPPL | 2018-08-21 |
| 35866 | SUPPL | 2013-10-17 |
| 4021 | SUPPL | 2013-10-15 |
| 35865 | SUPPL | 2009-04-23 |
| 35864 | SUPPL | 2009-04-03 |
| 14148 | SUPPL | 2009-04-03 |
| 26463 | SUPPL | 2009-03-05 |
| 26462 | SUPPL | 2009-03-05 |
| 4020 | SUPPL | 2009-03-05 |
| 44086 | ORIG | 2003-12-09 |
| 35863 | ORIG | 2001-11-08 |
| 21350 | ORIG | 2001-11-08 |
| 4019 | ORIG | 2001-11-08 |