Application 021488
- Type
- NDA
- Sponsor
- TOLMAR THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELIGARD | LEUPROLIDE ACETATE | INJECTABLE;SUBCUTANEOUS | 30MG/VIAL | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62935-302 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-303 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85889 | SUPPL | 2026-05-12 |
| 85854 | SUPPL | 2026-05-08 |
| 81371 | SUPPL | 2025-02-25 |
| 81346 | SUPPL | 2025-02-25 |
| 81015 | SUPPL | 2025-02-06 |
| 80965 | SUPPL | 2025-02-06 |
| 78531 | SUPPL | 2024-05-22 |
| 78530 | SUPPL | 2024-05-22 |
| 77295 | SUPPL | 2024-01-25 |
| 77287 | SUPPL | 2024-01-24 |
| 74862 | SUPPL | 2023-07-21 |
| 74861 | SUPPL | 2023-07-21 |
| 74852 | SUPPL | 2023-07-21 |
| 74851 | SUPPL | 2023-07-21 |
| 57735 | SUPPL | 2019-02-21 |
| 57698 | SUPPL | 2019-02-19 |
| 37058 | SUPPL | 2016-03-03 |
| 5526 | SUPPL | 2016-03-02 |
| 37057 | SUPPL | 2014-10-15 |
| 5525 | SUPPL | 2014-10-14 |
| 27921 | SUPPL | 2013-03-01 |
| 15589 | SUPPL | 2013-03-01 |
| 23667 | ORIG | 2011-12-20 |
| 27920 | SUPPL | 2011-04-11 |
| 15588 | SUPPL | 2011-04-11 |
| 27919 | SUPPL | 2011-01-20 |
| 15587 | SUPPL | 2011-01-20 |
| 27918 | SUPPL | 2010-10-13 |
| 15586 | SUPPL | 2010-10-12 |
| 5524 | SUPPL | 2007-11-19 |
| 37056 | SUPPL | 2007-11-13 |
| 27917 | ORIG | 2004-06-03 |
| 5523 | SUPPL | 2004-01-14 |
| 21688 | ORIG | 2003-05-08 |
| 37055 | ORIG | 2003-02-13 |