← FDA DRUG APPROVALS

FDA NDA · NDA020708

LUPRON DEPOT

leuprolide acetate

Sponsor: ABBVIE ENDOCRINE INC

APPLICATION
NDA020708
TYPE
NDA
ORIGINAL APPROVAL
1997-03-07
LATEST ACTION
2025-09-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LUPRON DEPOT · ReferencePrescription
LEUPROLIDE ACETATE 11.25MG · INJECTABLE · INJECTION

Approval history

2025-09-10Labeling · Supplement 40 · standard — Letter ↗AP
2025-09-10Labeling · Supplement 41 · standard — Letter ↗AP
2020-03-18Labeling · Supplement 38 · standard — Label ↗AP
2018-04-18Labeling · Supplement 35 · standard — Label ↗AP
2013-10-30Labeling · Supplement 34 · standard — Label ↗AP
2012-03-28Labeling · Supplement 31 · unknown — Letter ↗AP
2012-01-23Labeling · Supplement 33 · unknown — Letter ↗AP
2011-06-14Labeling · Supplement 32 · unknown — Letter ↗AP
2010-10-29Labeling · Supplement 30 · unknown — Label ↗AP
2009-06-02Labeling · Supplement 29 · standard — Letter ↗AP
2007-10-31Labeling · Supplement 26 · standard — Letter ↗AP
2005-09-15Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP
2005-09-15Labeling · Supplement 21 · standard — Review ↗AP
2004-01-15Labeling · Supplement 15 · standard — Letter ↗AP
2004-01-12Labeling · Supplement 18 · standard — Letter ↗AP
2002-09-20Manufacturing (CMC) · Supplement 16 · standardAP
2002-05-23Manufacturing (CMC) · Supplement 14 · standardAP
2001-11-14Labeling · Supplement 13 · standardAP
2001-09-21Efficacy · Supplement 11 · standard — Label ↗AP
2001-07-23Manufacturing (CMC) · Supplement 12 · 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
1999-02-11Efficacy · Supplement 5 · standard — Review ↗AP
1998-07-29Manufacturing (CMC) · Supplement 4 · standardAP
1998-04-09Labeling · Supplement 3 · standard — Review ↗AP
1997-12-23Manufacturing (CMC) · Supplement 2 · standardAP
1997-09-04Labeling · Supplement 1 · standardAP
1997-03-07Type 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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