Application 021731
- Type
- NDA
- Sponsor
- TOLMAR THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELIGARD | LEUPROLIDE ACETATE | INJECTABLE;SUBCUTANEOUS | 45MG/VIAL | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62935-452 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-453 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85890 | SUPPL | 2026-05-12 |
| 85855 | SUPPL | 2026-05-08 |
| 81372 | SUPPL | 2025-02-25 |
| 81347 | SUPPL | 2025-02-25 |
| 81016 | SUPPL | 2025-02-06 |
| 80966 | SUPPL | 2025-02-06 |
| 78533 | SUPPL | 2024-05-22 |
| 78532 | SUPPL | 2024-05-22 |
| 77296 | SUPPL | 2024-01-25 |
| 77288 | SUPPL | 2024-01-24 |
| 74864 | SUPPL | 2023-07-21 |
| 74863 | SUPPL | 2023-07-21 |
| 74857 | SUPPL | 2023-07-21 |
| 74855 | SUPPL | 2023-07-21 |
| 72745 | SUPPL | 2022-11-29 |
| 57734 | SUPPL | 2019-02-21 |
| 57697 | SUPPL | 2019-02-19 |
| 37552 | SUPPL | 2016-03-03 |
| 6079 | SUPPL | 2016-03-02 |
| 37551 | SUPPL | 2014-10-15 |
| 6078 | SUPPL | 2014-10-14 |
| 37550 | SUPPL | 2013-03-01 |
| 28490 | SUPPL | 2013-03-01 |
| 23674 | ORIG | 2011-12-20 |
| 37549 | SUPPL | 2011-04-11 |
| 28489 | SUPPL | 2011-04-11 |
| 16276 | SUPPL | 2011-01-20 |
| 6077 | SUPPL | 2011-01-20 |
| 28488 | SUPPL | 2010-10-13 |
| 37548 | SUPPL | 2010-10-12 |
| 6076 | SUPPL | 2007-11-19 |
| 16275 | SUPPL | 2007-11-13 |
| 28487 | SUPPL | 2006-10-05 |
| 21796 | ORIG | 2006-09-27 |