Lupron Depot

NDA 19943, held by Abbvie Endocrine Inc. Leuprolide Acetate.

As of Nov 14, 2026, NDA 19943 (Lupron Depot), held by Abbvie Endocrine Inc, was first approved by FDA on Mar 30, 1995, with 31 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1995
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Mar 30, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lupron Depot3.75MG · injectable; injection	Leuprolide Acetate	Rx

All 32 submissions, including labeling and manufacturing supplements


Sep 10, 2025	Supplement 41Labeling · Standard review	Approved	Letter Label
Sep 10, 2025	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 27, 2023	Supplement 39Labeling · Standard review	Approved	Label Letter
Feb 12, 2021	Supplement 35Labeling · Standard review	Approved	Label Letter
Oct 30, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Mar 28, 2012	Supplement 31Labeling	Approved	Letter Label
Jan 23, 2012	Supplement 33Labeling	Approved	Letter Label
Jun 14, 2011	Supplement 32Labeling	Approved	Letter Label
Oct 29, 2010	Supplement 30Labeling	Approved	Letter Label
Jun 2, 2009	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 31, 2007	Supplement 26Labeling · Standard review	Approved	Letter
Sep 15, 2005	Supplement 24Labeling · Standard review	Approved	Review Letter
Sep 15, 2005	Supplement 22Manufacturing · Standard review	Approved	Review Letter
Jan 15, 2004	Supplement 18Labeling · Standard review	Approved	Letter
Jan 12, 2004	Supplement 21Labeling · Standard review	Approved	Letter
Sep 20, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
May 23, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 21, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 14, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Mar 1, 2001	Supplement 14Labeling · Standard review	Approved	None posted
Jan 24, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
May 12, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
May 11, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 13, 1999	Supplement 10Manufacturing · Standard review	Approved	Review
Jun 30, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 27, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 12, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Dec 12, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Oct 26, 1995	Supplement 3Manufacturing · Standard review	Approved	Review
Sep 22, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 11, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 30, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 19943
Drugs@FDA: Overview at FDA
Company: AbbVie Endocrine

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