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FDA NDA · NDA020264

MEGACE

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APPLICATION
NDA020264
TYPE
NDA
ORIGINAL APPROVAL
1993-09-10
LATEST ACTION
2019-07-18
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

MEGACE · ReferenceDiscontinued
MEGESTROL ACETATE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2019-07-18Labeling · Supplement 21 · standard — Label ↗AP
2016-05-02Manufacturing (CMC) · Supplement 20AP
2012-04-08Labeling · Supplement 17 · standard — Letter ↗AP
2003-05-01Labeling · Supplement 11 · standard — Letter ↗AP
2002-04-09Labeling · Supplement 9 · standard — Letter ↗AP
2000-07-27Manufacturing (CMC) · Supplement 8AP
1998-06-25Manufacturing (CMC) · Supplement 6AP
1998-03-24Manufacturing (CMC) · Supplement 5AP
1997-08-08Labeling · Supplement 4 · standardAP
1996-10-22Labeling · Supplement 3 · standardAP
1994-11-04Labeling · Supplement 1 · standardAP
1994-07-29Manufacturing (CMC) · Supplement 2AP
1993-09-10Type 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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