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Lupron Depot-Ped Kit

Treats central precocious puberty (CPP). NDA 20263, held by Abbvie Endocrine Inc. Leuprolide Acetate.

As of Nov 13, 2026, NDA 20263 (Lupron Depot-Ped Kit), held by Abbvie Endocrine Inc, was first approved by FDA on Apr 16, 1993, with 40 approved supplements and 0 published complete response letters.

First approved: Apr 16, 1993
Review: Standard
Supplements approved: 40
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 41 submissions below

Date	Submission	Status	Documents
May 22, 2025	Supplement 56Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 14, 2023	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 8, 2011	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 15, 2011	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 16, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

8 strengths and forms

Product	Active ingredient	Marketing
Lupron Depot-Ped Kit7.5MG · powder;intramuscular	Leuprolide Acetate	RxReference drug
Lupron Depot-Ped Kit3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intramuscular	Leuprolide Acetate	DiscontinuedReference drug
Lupron Depot-Ped Kit7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;intramuscular	Leuprolide Acetate	DiscontinuedReference drug
Lupron Depot-Ped Kit11.25MG · powder;intramuscular	Leuprolide Acetate	RxReference drug
Lupron Depot-Ped Kit15MG · powder;intramuscular	Leuprolide Acetate	RxReference drug
Lupron Depot-Ped Kit11.25MG · powder;intramuscular	Leuprolide Acetate	RxReference drug
Lupron Depot-Ped Kit30MG · powder;intramuscular	Leuprolide Acetate	RxReference drug
Lupron Depot-Ped Kit45MG · powder;intramuscular	Leuprolide Acetate	RxReference drug

All 41 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 14, 2025	Supplement 57Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 23, 2025	Supplement 58Labeling · Standard review	Approved	Label Letter
May 22, 2025	Supplement 56Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 4, 2023	Supplement 54Labeling · Standard review	Approved	Label Letter
Apr 14, 2023	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 22, 2022	Supplement 50Labeling · Standard review	Approved	Label Letter
Nov 12, 2021	Supplement 48Labeling · Standard review	Approved	Letter
Mar 11, 2021	Supplement 47Labeling · Standard review	Approved	Letter Label
Mar 11, 2021	Supplement 44Labeling · Standard review	Approved	Letter Label
Apr 7, 2020	Supplement 46Labeling · Standard review	Approved	Label Letter
May 19, 2017	Supplement 42Labeling · Standard review	Approved	Review Letter Label
May 14, 2013	Supplement 39Labeling · Standard review	Approved	Label Letter
Oct 8, 2011	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 15, 2011	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2010	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 24, 2009	Supplement 33Labeling · Standard review	Approved	Letter Label
Jul 31, 2008	Supplement 30Labeling · Standard review	Approved	Letter
Feb 16, 2006	Supplement 28Labeling · Standard review	Approved	Review Letter Label
Nov 9, 2005	Supplement 26Manufacturing · Standard review	Approved	Letter Label
Mar 2, 2004	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 23, 2003	Supplement 23Labeling · Standard review	Approved	Letter
Oct 28, 2003	Supplement 22Labeling · Standard review	Approved	Letter
Sep 24, 2002	Supplement 20Manufacturing · Standard review	Approved	Letter
May 16, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 8, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 6, 2001	Supplement 17Labeling · Standard review	Approved	None posted
Jan 26, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
May 12, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
May 11, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 13, 1999	Supplement 12Manufacturing · Standard review	Approved	Review
Jun 30, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 27, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 10, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Oct 26, 1995	Supplement 6Manufacturing · Standard review	Approved	Review
Sep 22, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 11, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 24, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Nov 7, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 14, 1994	Supplement 3Manufacturing · Standard review	Approved	Review
Jan 21, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 16, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20263
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