Application 020708
- Type
- NDA
- Sponsor
- ABBVIE ENDOCRINE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUPRON DEPOT | LEUPROLIDE ACETATE | INJECTABLE;INJECTION | 11.25MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-3663 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3663 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3663 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
| 0074-3663 | Lupron Depot | leuprolide acetate | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83334 | SUPPL | 2025-09-11 |
| 83333 | SUPPL | 2025-09-11 |
| 83330 | SUPPL | 2025-09-11 |
| 83329 | SUPPL | 2025-09-11 |
| 62431 | SUPPL | 2020-04-03 |
| 62416 | SUPPL | 2020-04-02 |
| 53771 | SUPPL | 2018-04-23 |
| 53743 | SUPPL | 2018-04-19 |
| 13257 | SUPPL | 2013-11-05 |
| 3153 | SUPPL | 2013-10-31 |
| 3151 | SUPPL | 2012-04-02 |
| 35184 | SUPPL | 2012-03-28 |
| 25588 | SUPPL | 2012-01-25 |
| 35186 | SUPPL | 2012-01-23 |
| 44066 | ORIG | 2011-12-20 |
| 35185 | SUPPL | 2011-06-16 |
| 3152 | SUPPL | 2011-06-16 |
| 3150 | SUPPL | 2010-11-02 |
| 35183 | SUPPL | 2010-10-29 |
| 25587 | SUPPL | 2009-06-08 |
| 35182 | SUPPL | 2009-06-04 |
| 3149 | SUPPL | 2007-11-08 |
| 41598 | SUPPL | 2007-07-09 |
| 41597 | SUPPL | 2007-07-09 |
| 41596 | SUPPL | 2007-07-09 |
| 25586 | SUPPL | 2005-10-20 |
| 3148 | SUPPL | 2005-10-20 |
| 3147 | SUPPL | 2004-01-22 |
| 25585 | SUPPL | 2004-01-14 |
| 20864 | ORIG | 2003-08-08 |
| 20866 | SUPPL | 2001-11-14 |
| 13256 | SUPPL | 2001-09-21 |
| 3146 | SUPPL | 2001-09-21 |
| 20865 | SUPPL | 2001-08-06 |
| 41595 | SUPPL | 1999-06-22 |
| 3145 | SUPPL | 1999-02-11 |
| 25584 | SUPPL | 1998-04-09 |