Application 019010
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUPRON | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 1MG/0.2ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85882 | SUPPL | 2026-05-12 |
| 85845 | SUPPL | 2026-05-08 |
| 83625 | SUPPL | 2025-10-02 |
| 83621 | SUPPL | 2025-10-01 |
| 83589 | SUPPL | 2025-09-30 |
| 83475 | SUPPL | 2025-09-25 |
| 57626 | ORIG | 2019-02-15 |
| 57141 | SUPPL | 2019-01-09 |
| 56830 | SUPPL | 2018-12-20 |
| 53721 | SUPPL | 2018-04-18 |
| 48984 | SUPPL | 2017-07-14 |
| 48954 | SUPPL | 2017-07-12 |
| 48497 | SUPPL | 2017-05-23 |
| 48467 | SUPPL | 2017-05-19 |
| 48466 | SUPPL | 2017-05-19 |
| 11413 | SUPPL | 2014-07-11 |
| 1200 | SUPPL | 2014-07-11 |
| 23546 | ORIG | 2011-12-20 |
| 1199 | SUPPL | 2011-03-24 |
| 11412 | SUPPL | 2011-03-21 |
| 33686 | SUPPL | 2011-01-20 |
| 16168 | SUPPL | 2011-01-20 |
| 11411 | SUPPL | 2010-05-07 |
| 1198 | SUPPL | 2010-05-04 |
| 1197 | SUPPL | 2007-09-25 |
| 40859 | SUPPL | 2007-07-09 |
| 40858 | SUPPL | 2007-07-09 |
| 20196 | SUPPL | 2007-07-09 |
| 20195 | SUPPL | 2007-07-09 |
| 1196 | SUPPL | 2005-10-20 |
| 1195 | SUPPL | 2004-10-22 |
| 1194 | SUPPL | 2003-12-02 |