Manages endometriosis, including pain relief and reduction of endometriotic lesions. NDA 20011, held by Abbvie Endocrine Inc. Leuprolide Acetate.
As of Nov 13, 2026, NDA 20011 (Lupron Depot), held by Abbvie Endocrine Inc, was first approved by FDA on Oct 22, 1990, with 36 approved supplements and 0 published complete response letters.
LUPRON DEPOT 3.75 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 3.75 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 21Efficacy (new indication or use) · Standard review | Approved | |
| Apr 9, 1998 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 1990 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lupron Depot3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Leuprolide Acetate | DiscontinuedReference drug |
| Lupron Depot3.75MG · injectable;injection | Leuprolide Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2025 | Supplement 48Labeling · Standard review | Approved | |
| Sep 10, 2025 | Supplement 47Labeling · Standard review | Approved | |
| Jan 27, 2023 | Supplement 46Labeling · Standard review | Approved | |
| Feb 12, 2021 | Supplement 42Labeling · Standard review | Approved | |
| Oct 30, 2013 | Supplement 41Labeling · Standard review | Approved | |
| Mar 28, 2012 | Supplement 38Labeling | Approved | |
| Jan 23, 2012 | Supplement 40Labeling | Approved | |
| Jun 14, 2011 | Supplement 39Labeling | Approved | |
| Oct 29, 2010 | Supplement 37Labeling | Approved | |
| Jun 2, 2009 | Supplement 36Labeling · Standard review | Approved | |
| Oct 31, 2007 | Supplement 33Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 31Labeling · Standard review | Approved | |
| Sep 15, 2005 | Supplement 29Manufacturing · Standard review | Approved | |
| Jan 15, 2004 | Supplement 25Labeling · Standard review | Approved | |
| Jan 12, 2004 | Supplement 28Labeling · Standard review | Approved | |
| Sep 20, 2002 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 23, 2002 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2002 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 14, 2001 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 21, 2001 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 2001 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 24, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 12, 2000 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 11, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1999 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1998 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1998 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jun 27, 1997 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1996 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 26, 1995 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1995 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 11, 1995 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1994 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1994 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 26, 1994 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 14, 1994 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1990 | Original applicationNew dosage form · Standard 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
