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FDA NDA · NDA050742

STROMECTOL

ivermectin

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA050742
TYPE
NDA
ORIGINAL APPROVAL
1996-11-22
LATEST ACTION
2022-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

STROMECTOL · ReferencePrescription
IVERMECTIN 3MG · TABLET · ORAL
STROMECTOL · ReferenceDiscontinued
IVERMECTIN 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2022-03-14Labeling · Supplement 30 · standard — Letter ↗AP
2015-05-11Manufacturing (CMC) · Supplement 28AP
2015-04-07Manufacturing (CMC) · Supplement 27AP
2009-12-15Labeling · Supplement 26 · standard — Label ↗AP
2009-06-11Labeling · Supplement 25 · standard — Letter ↗AP
2009-06-11Labeling · Supplement 24 · standard — Label ↗AP
2009-05-01Labeling · Supplement 23 · standard — Label ↗AP
2008-09-12Labeling · Supplement 22 · standard — Label ↗AP
2008-02-26Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2007-09-26Labeling · Supplement 19 · standard — Label ↗AP
2007-09-26Labeling · Supplement 21 · standard — Label ↗AP
2006-01-20Labeling · Supplement 17 · standard — Label ↗AP
2006-01-20Labeling · Supplement 18 · standard — Label ↗AP
2004-11-18Labeling · Supplement 15 · standard — Label ↗AP
2004-02-12Labeling · Supplement 12 · standard — Letter ↗AP
2004-02-12Labeling · Supplement 13 · standard — Label ↗AP
2003-01-15Labeling · Supplement 11 · standard — Label ↗AP
2002-12-12Manufacturing (CMC) · Supplement 8AP
2002-05-28Manufacturing (CMC) · Supplement 7AP
2001-07-17Manufacturing (CMC) · Supplement 6AP
2001-01-04Labeling · Supplement 2 · standardAP
2001-01-04Labeling · Supplement 5 · standardAP
1999-11-10Manufacturing (CMC) · Supplement 4AP
1999-08-04Manufacturing (CMC) · Supplement 3AP
1998-10-08Manufacturing (CMC) · Supplement 1 — Review ↗AP
1996-11-22Type 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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