← FDA DRUG APPROVALS

FDA NDA · NDA019010

LUPRON

Sponsor: ABBVIE ENDOCRINE INC

APPLICATION
NDA019010
TYPE
NDA
ORIGINAL APPROVAL
1985-04-09
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LUPRON · ReferenceDiscontinued
LEUPROLIDE ACETATE 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · SUBCUTANEOUS

Approval history

2026-05-06Labeling · Supplement 44 · standard — Letter ↗AP
2025-09-30Labeling · Supplement 42 · standard — Label ↗AP
2025-09-23Labeling · Supplement 43 · standard — Label ↗AP
2018-12-10Labeling · Supplement 41 · standard — Letter ↗AP
2017-07-11Labeling · Supplement 39 · standard — Label ↗AP
2017-05-19Labeling · Supplement 38 · standard — Label ↗AP
2014-07-10Labeling · Supplement 37 · standard — Label ↗AP
2011-03-21Labeling · Supplement 35 · standard — Label ↗AP
2011-01-14Labeling · Supplement 36 · 901 required — Letter ↗AP
2010-04-28Labeling · Supplement 33 · standard — Label ↗AP
2007-09-14Labeling · Supplement 32 · standard — Letter ↗AP
2005-09-15Labeling · Supplement 31 · standard — Letter ↗AP
2004-10-18Labeling · Supplement 28 · standard — Letter ↗AP
2003-11-25Labeling · Supplement 27 · standard — Letter ↗AP
2002-05-16Manufacturing (CMC) · Supplement 24 · priority — Review ↗AP
2002-05-16Manufacturing (CMC) · Supplement 23 · priority — Review ↗AP
2000-12-21Manufacturing (CMC) · Supplement 22 · priorityAP
1999-11-22Manufacturing (CMC) · Supplement 21 · priorityAP
1998-09-25Manufacturing (CMC) · Supplement 20 · priorityAP
1998-01-08Manufacturing (CMC) · Supplement 19 · priorityAP
1997-07-07Manufacturing (CMC) · Supplement 17 · priorityAP
1997-07-07Manufacturing (CMC) · Supplement 18 · priorityAP
1996-05-28Manufacturing (CMC) · Supplement 15 · priorityAP
1996-04-24Manufacturing (CMC) · Supplement 14 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 12 · priorityAP
1994-05-09Manufacturing (CMC) · Supplement 11 · priorityAP
1993-06-09Manufacturing (CMC) · Supplement 10 · priorityAP
1992-07-07Manufacturing (CMC) · Supplement 9 · priorityAP
1991-10-21Manufacturing (CMC) · Supplement 8 · priorityAP
1988-05-09Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
1988-01-19Manufacturing (CMC) · Supplement 3 · priorityAP
1987-03-12Labeling · Supplement 4AP
1987-01-14Manufacturing (CMC) · Supplement 5 · priorityAP
1986-07-10Manufacturing (CMC) · Supplement 2 · priorityAP
1985-04-09Type 1 - New Molecular Entity · Original · priority — 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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