Application 213150
- Type
- NDA
- Sponsor
- TOLMAR
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENSOLVI | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 45MG | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-153 | Fensolvi | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 83471 | SUPPL | 2025-09-25 |
| 83470 | SUPPL | 2025-09-25 |
| 83428 | SUPPL | 2025-09-24 |
| 82168 | SUPPL | 2025-05-08 |
| 79945 | SUPPL | 2024-10-21 |
| 79914 | SUPPL | 2024-10-18 |
| 72730 | SUPPL | 2022-11-28 |
| 72729 | SUPPL | 2022-11-28 |
| 70823 | SUPPL | 2022-04-27 |
| 70822 | SUPPL | 2022-04-27 |
| 70812 | SUPPL | 2022-04-26 |
| 65951 | ORIG | 2021-01-21 |
| 62822 | ORIG | 2020-05-05 |
| 62816 | ORIG | 2020-05-04 |
| 62815 | ORIG | 2020-05-04 |