Lupron

NDA 19010, held by Abbvie Endocrine Inc. Leuprolide Acetate.

As of Nov 13, 2026, NDA 19010 (Lupron), held by Abbvie Endocrine Inc, was first approved by FDA on Apr 9, 1985, with 34 approved supplements and 0 published complete response letters.

First approved: Apr 9, 1985
Review: Priority
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Apr 9, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lupron14MG/2.8ML (1MG/0.2ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;subcutaneous	Leuprolide Acetate	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 6, 2026	Supplement 44Labeling · Standard review	Approved	Label Letter
Sep 30, 2025	Supplement 42Labeling · Standard review	Approved	Letter Label
Sep 23, 2025	Supplement 43Labeling · Standard review	Approved	Letter Label
Dec 10, 2018	Supplement 41Labeling · Standard review	Approved	Label Letter
Jul 11, 2017	Supplement 39Labeling · Standard review	Approved	Letter Label
May 19, 2017	Supplement 38Labeling · Standard review	Approved	Review Letter Label Medication Guide
Jul 10, 2014	Supplement 37Labeling · Standard review	Approved	Letter Label
Mar 21, 2011	Supplement 35Labeling · Standard review	Approved	Letter Label
Jan 14, 2011	Supplement 36Labeling	Approved	Letter Label
Apr 28, 2010	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 14, 2007	Supplement 32Labeling · Standard review	Approved	Letter
Sep 15, 2005	Supplement 31Labeling · Standard review	Approved	Review Letter
Oct 18, 2004	Supplement 28Labeling · Standard review	Approved	Letter
Nov 25, 2003	Supplement 27Labeling · Standard review	Approved	Letter
May 16, 2002	Supplement 24Manufacturing · Priority review	Approved	Review
May 16, 2002	Supplement 23Manufacturing · Priority review	Approved	Review
Dec 21, 2000	Supplement 22Manufacturing · Priority review	Approved	None posted
Nov 22, 1999	Supplement 21Manufacturing · Priority review	Approved	None posted
Sep 25, 1998	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 8, 1998	Supplement 19Manufacturing · Priority review	Approved	None posted
Jul 7, 1997	Supplement 18Manufacturing · Priority review	Approved	None posted
Jul 7, 1997	Supplement 17Manufacturing · Priority review	Approved	None posted
May 28, 1996	Supplement 15Manufacturing · Priority review	Approved	None posted
Apr 24, 1996	Supplement 14Manufacturing · Priority review	Approved	None posted
May 9, 1994	Supplement 12Manufacturing · Priority review	Approved	None posted
May 9, 1994	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 9, 1993	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 7, 1992	Supplement 9Manufacturing · Priority review	Approved	None posted
Oct 21, 1991	Supplement 8Manufacturing · Priority review	Approved	None posted
May 9, 1988	Supplement 6Manufacturing · Priority review	Approved	Review
Jan 19, 1988	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 12, 1987	Supplement 4Labeling	Approved	None posted
Jan 14, 1987	Supplement 5Manufacturing · Priority review	Approved	None posted
Jul 10, 1986	Supplement 2Manufacturing · Priority review	Approved	None posted
Apr 9, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 19010
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