Manages endometriosis, including pain relief and reduction of endometriotic lesions. NDA 20708, held by Abbvie Endocrine Inc. Leuprolide Acetate.
As of Nov 13, 2026, NDA 20708 (Lupron Depot), held by Abbvie Endocrine Inc, was first approved by FDA on Mar 7, 1997, with 30 approved supplements and 0 published complete response letters.
LUPRON DEPOT 11.25 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Limitations of Use: The total duration of therapy with LUPRON DEPOT 11.25 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density. ( 1.1, 2.1, 5.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2001 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 11, 1999 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 7, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lupron Depot11.25MG · injectable;injection | Leuprolide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2025 | Supplement 41Labeling · Standard review | Approved | |
| Sep 10, 2025 | Supplement 40Labeling · Standard review | Approved | |
| Mar 18, 2020 | Supplement 38Labeling · Standard review | Approved | |
| Apr 18, 2018 | Supplement 35Labeling · Standard review | Approved | |
| Oct 30, 2013 | Supplement 34Labeling · Standard review | Approved | |
| Mar 28, 2012 | Supplement 31Labeling | Approved | |
| Jan 23, 2012 | Supplement 33Labeling | Approved | |
| Jun 14, 2011 | Supplement 32Labeling | Approved | |
| Oct 29, 2010 | Supplement 30Labeling | Approved | |
| Jun 2, 2009 | Supplement 29Labeling · Standard review | Approved | |
| Oct 31, 2007 | Supplement 26Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 20Manufacturing · Standard review | Approved | |
| Sep 15, 2005 | Supplement 21Labeling · Standard review | Approved | |
| Jan 15, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Jan 12, 2004 | Supplement 18Labeling · Standard review | Approved | |
| Sep 20, 2002 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 23, 2002 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 14, 2001 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 21, 2001 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 23, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2001 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 24, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 12, 2000 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 11, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1999 | Supplement 6Manufacturing · Standard review | Approved | |
| Feb 11, 1999 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1998 | Supplement 3Labeling · Standard review | Approved | |
| Dec 23, 1997 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1997 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 7, 1997 | Original applicationNew dosage form · Standard review | Approved |
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
