Application 021379
- Type
- NDA
- Sponsor
- TOLMAR THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELIGARD | LEUPROLIDE ACETATE | INJECTABLE;SUBCUTANEOUS | 22.5MG/VIAL | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62935-222 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-223 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85888 | SUPPL | 2026-05-12 |
| 85853 | SUPPL | 2026-05-08 |
| 81370 | SUPPL | 2025-02-25 |
| 81345 | SUPPL | 2025-02-25 |
| 81014 | SUPPL | 2025-02-06 |
| 80964 | SUPPL | 2025-02-06 |
| 78529 | SUPPL | 2024-05-22 |
| 78528 | SUPPL | 2024-05-22 |
| 77294 | SUPPL | 2024-01-25 |
| 77286 | SUPPL | 2024-01-24 |
| 74860 | SUPPL | 2023-07-21 |
| 74859 | SUPPL | 2023-07-21 |
| 74848 | SUPPL | 2023-07-21 |
| 74849 | SUPPL | 2023-07-20 |
| 57736 | SUPPL | 2019-02-21 |
| 57699 | SUPPL | 2019-02-19 |
| 15347 | SUPPL | 2016-03-03 |
| 27644 | SUPPL | 2016-03-02 |
| 15346 | SUPPL | 2014-10-15 |
| 5231 | SUPPL | 2014-10-14 |
| 36801 | SUPPL | 2013-03-01 |
| 27643 | SUPPL | 2013-03-01 |
| 23652 | ORIG | 2011-12-20 |
| 36800 | SUPPL | 2011-04-11 |
| 27642 | SUPPL | 2011-04-11 |
| 15345 | SUPPL | 2011-01-20 |
| 5230 | SUPPL | 2011-01-20 |
| 5229 | SUPPL | 2010-10-13 |
| 15344 | SUPPL | 2010-10-12 |
| 42131 | SUPPL | 2008-07-31 |
| 27641 | SUPPL | 2007-11-19 |
| 15343 | SUPPL | 2007-11-13 |
| 5228 | SUPPL | 2004-06-03 |
| 42130 | ORIG | 2002-07-24 |
| 15342 | ORIG | 2002-07-24 |
| 5227 | ORIG | 2002-07-24 |