Application 019943
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE; INJECTION | 3.75MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83336 | SUPPL | 2025-09-11 |
| 83335 | SUPPL | 2025-09-11 |
| 83322 | SUPPL | 2025-09-11 |
| 83321 | SUPPL | 2025-09-11 |
| 73347 | SUPPL | 2023-01-31 |
| 73339 | SUPPL | 2023-01-30 |
| 66297 | SUPPL | 2021-02-18 |
| 66216 | SUPPL | 2021-02-16 |
| 34115 | SUPPL | 2013-11-05 |
| 1833 | SUPPL | 2013-10-31 |
| 1831 | SUPPL | 2012-04-02 |
| 34112 | SUPPL | 2012-03-28 |
| 1832 | SUPPL | 2012-01-25 |
| 34114 | SUPPL | 2012-01-23 |
| 44040 | ORIG | 2011-12-20 |
| 34113 | SUPPL | 2011-06-16 |
| 19863 | SUPPL | 2011-06-16 |
| 19862 | SUPPL | 2010-11-02 |
| 12082 | SUPPL | 2010-10-29 |
| 19861 | SUPPL | 2009-06-08 |
| 34111 | SUPPL | 2009-06-04 |
| 1830 | SUPPL | 2007-11-08 |
| 41106 | SUPPL | 2007-07-09 |
| 41105 | SUPPL | 2007-07-09 |
| 41104 | SUPPL | 2007-07-09 |
| 20431 | SUPPL | 2007-07-09 |
| 20430 | ORIG | 2007-07-09 |
| 1829 | SUPPL | 2005-10-20 |
| 1828 | SUPPL | 2005-10-20 |
| 19859 | SUPPL | 2004-01-22 |
| 19860 | SUPPL | 2004-01-14 |