Treats advanced prostate cancer. NDA 19732, held by Abbvie Endocrine Inc. Leuprolide Acetate.
As of Nov 13, 2026, NDA 19732 (Lupron Depot), held by Abbvie Endocrine Inc, was first approved by FDA on Jan 26, 1989, with 38 approved supplements and 0 published complete response letters.
LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2022 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 1989 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lupron Depot7.5MG · injectable;injection | Leuprolide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2025 | Supplement 50Labeling · Standard review | Approved | |
| Mar 21, 2024 | Supplement 49Labeling · Standard review | Approved | |
| Dec 4, 2023 | Supplement 48Labeling · Standard review | Approved | |
| Apr 18, 2022 | Supplement 45Efficacy (new indication or use) · Standard review | Approved | |
| Mar 4, 2019 | Supplement 44Labeling · Standard review | Approved | |
| Dec 10, 2018 | Supplement 43Labeling · Standard review | Approved | |
| Jun 6, 2016 | Supplement 42Labeling · Standard review | Approved | |
| Jun 27, 2014 | Supplement 41Labeling · Standard review | Approved | |
| Jul 10, 2013 | Supplement 40Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 38Labeling | Approved | |
| Jan 14, 2011 | Supplement 37Labeling | Approved | |
| Apr 28, 2010 | Supplement 36Labeling · Standard review | Approved | |
| Apr 28, 2010 | Supplement 35Labeling · Standard review | Approved | |
| Apr 28, 2010 | Supplement 31Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 29Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 27Manufacturing · Priority review | Approved | |
| Jan 12, 2004 | Supplement 26Labeling · Standard review | Approved | |
| Sep 9, 2003 | Supplement 23Labeling · Standard review | Approved | |
| Sep 20, 2002 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| May 23, 2002 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Feb 21, 2002 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Mar 1, 2001 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 24, 2001 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| May 12, 2000 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| May 11, 2000 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Oct 4, 1999 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 13, 1999 | Supplement 16Manufacturing · Priority review | Approved | |
| Jun 30, 1998 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jan 9, 1998 | Supplement 12Labeling · Standard review | Approved | |
| Jun 27, 1997 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Oct 26, 1995 | Supplement 9Manufacturing · Priority review | Approved | |
| Sep 22, 1995 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 11, 1995 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Nov 8, 1994 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Apr 26, 1994 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 14, 1994 | Supplement 7Manufacturing · Priority review | Approved | |
| Mar 26, 1992 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Dec 14, 1990 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jan 26, 1989 | Original applicationNew dosage form · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
