Application 021343
- Type
- NDA
- Sponsor
- TOLMAR THERAP
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELIGARD | LEUPROLIDE ACETATE | INJECTABLE;SUBCUTANEOUS | 7.5MG/VIAL | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62935-752 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
| 62935-753 | ELIGARD | Leuprolide Acetate | TOLMAR PHARMACEUTICALS INC. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85887 | SUPPL | 2026-05-12 |
| 85852 | SUPPL | 2026-05-08 |
| 81369 | SUPPL | 2025-02-25 |
| 81344 | SUPPL | 2025-02-25 |
| 81013 | SUPPL | 2025-02-06 |
| 80963 | SUPPL | 2025-02-06 |
| 78527 | SUPPL | 2024-05-22 |
| 78526 | SUPPL | 2024-05-22 |
| 77293 | SUPPL | 2024-01-25 |
| 77285 | SUPPL | 2024-01-24 |
| 74858 | SUPPL | 2023-07-21 |
| 74856 | SUPPL | 2023-07-21 |
| 74847 | SUPPL | 2023-07-21 |
| 74846 | SUPPL | 2023-07-21 |
| 57733 | SUPPL | 2019-02-21 |
| 57696 | SUPPL | 2019-02-19 |
| 15225 | SUPPL | 2016-03-03 |
| 27529 | SUPPL | 2016-03-02 |
| 44988 | SUPPL | 2016-02-29 |
| 36699 | SUPPL | 2014-10-15 |
| 5094 | SUPPL | 2014-10-14 |
| 15224 | SUPPL | 2013-03-01 |
| 5093 | SUPPL | 2013-03-01 |
| 23647 | ORIG | 2011-12-20 |
| 36698 | SUPPL | 2011-04-11 |
| 5092 | SUPPL | 2011-04-11 |
| 27528 | SUPPL | 2011-01-20 |
| 15223 | SUPPL | 2011-01-20 |
| 27527 | SUPPL | 2010-10-13 |
| 36697 | SUPPL | 2010-10-12 |
| 5091 | SUPPL | 2007-11-19 |
| 36696 | SUPPL | 2007-11-13 |
| 27526 | SUPPL | 2004-01-14 |
| 5090 | SUPPL | 2003-07-08 |
| 5089 | SUPPL | 2002-04-01 |
| 36695 | ORIG | 2002-01-23 |
| 27525 | ORIG | 2002-01-23 |
| 21610 | ORIG | 2002-01-23 |