← FDA DRUG APPROVALS

FDA NDA · NDA020011

LUPRON DEPOT

leuprolide acetate

Sponsor: ABBVIE ENDOCRINE INC

APPLICATION
NDA020011
TYPE
NDA
ORIGINAL APPROVAL
1990-10-22
LATEST ACTION
2025-09-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

LUPRON DEPOT · ReferenceDiscontinued
LEUPROLIDE ACETATE 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 3.75MG · INJECTABLE · INJECTION

Approval history

2025-09-10Labeling · Supplement 48 · standard — Letter ↗AP
2025-09-10Labeling · Supplement 47 · standard — Letter ↗AP
2023-01-27Labeling · Supplement 46 · standard — Letter ↗AP
2021-02-12Labeling · Supplement 42 · standard — Letter ↗AP
2013-10-30Labeling · Supplement 41 · standard — Label ↗AP
2012-03-28Labeling · Supplement 38 · unknown — Letter ↗AP
2012-01-23Labeling · Supplement 40 · unknown — Label ↗AP
2011-06-14Labeling · Supplement 39 · unknown — Label ↗AP
2010-10-29Labeling · Supplement 37 · unknown — Letter ↗AP
2009-06-02Labeling · Supplement 36 · standard — Label ↗AP
2007-10-31Labeling · Supplement 33 · standard — Letter ↗AP
2005-09-15Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP
2005-09-15Labeling · Supplement 31 · standard — Letter ↗AP
2004-01-15Labeling · Supplement 25 · standard — Letter ↗AP
2004-01-12Labeling · Supplement 28 · standard — Letter ↗AP
2002-09-20Manufacturing (CMC) · Supplement 26 · standardAP
2002-05-23Manufacturing (CMC) · Supplement 24 · standardAP
2002-02-21Manufacturing (CMC) · Supplement 23 · standardAP
2001-11-14Labeling · Supplement 22 · standardAP
2001-09-21Efficacy · Supplement 21 · standard — Review ↗AP
2001-03-01Labeling · Supplement 20 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 19 · standardAP
2000-05-12Manufacturing (CMC) · Supplement 18 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 17 · standardAP
1999-08-13Manufacturing (CMC) · Supplement 16 · standardAP
1998-06-30Manufacturing (CMC) · Supplement 15 · standardAP
1998-04-09Efficacy · Supplement 14 · standard — Letter ↗AP
1997-06-27Manufacturing (CMC) · Supplement 11 · standardAP
1996-09-12Labeling · Supplement 10 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 6 · standardAP
1995-09-22Manufacturing (CMC) · Supplement 7 · standardAP
1995-08-11Manufacturing (CMC) · Supplement 8 · standardAP
1994-11-07Manufacturing (CMC) · Supplement 4 · standardAP
1994-07-21Labeling · Supplement 5 · standardAP
1994-04-26Labeling · Supplement 2 · standardAP
1994-02-14Manufacturing (CMC) · Supplement 3 · standardAP
1990-10-22Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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