← FDA DRUG APPROVALS

FDA NDA · NDA019732

LUPRON DEPOT

leuprolide acetate

Sponsor: ABBVIE ENDOCRINE INC

APPLICATION
NDA019732
TYPE
NDA
ORIGINAL APPROVAL
1989-01-26
LATEST ACTION
2025-08-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 7.5MG · INJECTABLE · INJECTION

Approval history

2025-08-18Labeling · Supplement 50 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 49 · standard — Letter ↗AP
2023-12-04Labeling · Supplement 48 · standard — Letter ↗AP
2022-04-18Efficacy · Supplement 45 · standard — Letter ↗AP
2019-03-04Labeling · Supplement 44 · standard — Label ↗AP
2018-12-10Labeling · Supplement 43 · standard — Letter ↗AP
2016-06-06Labeling · Supplement 42 · standard — Label ↗AP
2014-06-27Labeling · Supplement 41 · standard — Label ↗AP
2013-07-10Labeling · Supplement 40 · standard — Letter ↗AP
2012-02-17Labeling · Supplement 38 · unknown — Label ↗AP
2011-01-14Labeling · Supplement 37 · 901 required — Label ↗AP
2010-04-28Labeling · Supplement 36 · standard — Label ↗AP
2010-04-28Labeling · Supplement 35 · standard — Letter ↗AP
2010-04-28Labeling · Supplement 31 · standard — Label ↗AP
2005-09-15Labeling · Supplement 29 · standard — Review ↗AP
2005-09-15Manufacturing (CMC) · Supplement 27 · priority — Review ↗AP
2004-01-12Labeling · Supplement 26 · standard — Letter ↗AP
2003-09-09Labeling · Supplement 23 · standard — Letter ↗AP
2002-09-20Manufacturing (CMC) · Supplement 24 · priorityAP
2002-05-23Manufacturing (CMC) · Supplement 22 · priorityAP
2002-02-21Manufacturing (CMC) · Supplement 21 · priorityAP
2001-03-01Labeling · Supplement 20 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 19 · priorityAP
2000-05-12Manufacturing (CMC) · Supplement 18 · priorityAP
2000-05-11Manufacturing (CMC) · Supplement 17 · priorityAP
1999-10-04Labeling · Supplement 15 · standardAP
1999-08-13Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
1998-06-30Manufacturing (CMC) · Supplement 14 · priorityAP
1998-01-09Labeling · Supplement 12 · standard — Label ↗AP
1997-06-27Manufacturing (CMC) · Supplement 13 · priorityAP
1995-10-26Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP
1995-09-22Manufacturing (CMC) · Supplement 10 · priorityAP
1995-08-11Manufacturing (CMC) · Supplement 11 · priorityAP
1994-11-08Manufacturing (CMC) · Supplement 8 · priorityAP
1994-04-26Labeling · Supplement 6 · standardAP
1994-02-14Manufacturing (CMC) · Supplement 7 · priority — Review ↗AP
1992-03-26Manufacturing (CMC) · Supplement 3 · priorityAP
1990-12-14Manufacturing (CMC) · Supplement 2 · priorityAP
1989-01-26Type 3 - New Dosage Form · Original · priority — 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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