← FDA DRUG APPROVALS

FDA NDA · NDA020517

LUPRON DEPOT

leuprolide acetate

Sponsor: ABBVIE ENDOCRINE INC

APPLICATION
NDA020517
TYPE
NDA
ORIGINAL APPROVAL
1995-12-22
LATEST ACTION
2025-08-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 45MG · INJECTABLE · INJECTION
LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 22.5MG · INJECTABLE · INJECTION
LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 30MG · INJECTABLE · INJECTION

Approval history

2025-08-18Labeling · Supplement 47 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 46 · standard — Letter ↗AP
2023-12-04Labeling · Supplement 45 · standard — Label ↗AP
2022-04-18Efficacy · Supplement 43 · standard — Letter ↗AP
2019-03-04Labeling · Supplement 42 · standard — Label ↗AP
2018-12-10Labeling · Supplement 41 · standard — Letter ↗AP
2016-06-06Labeling · Supplement 38 · standard — Label ↗AP
2016-02-11Manufacturing (CMC) · Supplement 37 · standardAP
2014-06-27Labeling · Supplement 36 · standard — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 34 · standardAP
2013-07-10Labeling · Supplement 35 · standard — Label ↗AP
2012-07-18Labeling · Supplement 33 · standard — Label ↗AP
2011-06-17Labeling · Supplement 32 · standard — Label ↗AP
2011-06-17Efficacy · Supplement 30 · standard — Review ↗AP
2011-06-17Labeling · Supplement 25 · standard — Review ↗AP
2011-01-14Labeling · Supplement 31 · 901 required — Label ↗AP
2010-04-28Labeling · Supplement 28 · standard — Letter ↗AP
2010-04-28Labeling · Supplement 24 · standard — Label ↗AP
2010-04-28Labeling · Supplement 29 · standard — Label ↗AP
2005-09-15Manufacturing (CMC) · Supplement 18 · standard — Review ↗AP
2005-09-15Labeling · Supplement 19 · standard — Review ↗AP
2004-01-12Labeling · Supplement 16 · standard — Letter ↗AP
2003-09-09Labeling · Supplement 13 · standard — Letter ↗AP
2002-09-20Manufacturing (CMC) · Supplement 14 · standardAP
2002-05-23Manufacturing (CMC) · Supplement 12 · standardAP
2001-07-23Manufacturing (CMC) · Supplement 11 · standardAP
2001-03-01Labeling · Supplement 10 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 9 · standardAP
2000-05-12Manufacturing (CMC) · Supplement 8 · standardAP
2000-05-11Manufacturing (CMC) · Supplement 7 · standardAP
1999-08-13Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1998-07-29Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 4 · standardAP
1997-05-30Efficacy · Supplement 2 · standard — Review ↗AP
1996-12-03Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1995-12-22Type 3 - New Dosage Form · Original · standard — Review ↗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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