FDA NDA · NDA021778

MEGACE ES

Sponsor: ENDO OPERATIONS

APPLICATION

NDA021778

TYPE

NDA

ORIGINAL APPROVAL

2005-07-05

LATEST ACTION

2018-12-18

ROUTE

ORAL

DOSAGE FORM

SUSPENSION

MARKETING STATUS

Discontinued

Products

MEGACE ES · ReferenceDiscontinued

MEGESTROL ACETATE 125MG/ML · SUSPENSION · ORAL

2018-12-18Labeling · Supplement 24 · standard — Label ↗AP

2015-11-05Manufacturing (CMC) · Supplement 22 · standardAP

2014-10-16Manufacturing (CMC) · Supplement 19 · standardAP

2014-10-16Manufacturing (CMC) · Supplement 20 · standardAP

2014-09-18Labeling · Supplement 18 · standard — Label ↗AP

2014-07-31Manufacturing (CMC) · Supplement 17 · standardAP

2014-03-17Manufacturing (CMC) · Supplement 15 · standardAP

2013-06-14Manufacturing (CMC) · Supplement 14 · standardAP

2013-05-14Labeling · Supplement 16 · standard — Letter ↗AP

2013-01-25Manufacturing (CMC) · Supplement 13 · standardAP

2010-07-21Labeling · Supplement 8 · standard — Label ↗AP

2008-08-12Labeling · Supplement 7 · standard — Letter ↗AP

2007-03-19Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP

2007-03-19Labeling · Supplement 2 · standard — Letter ↗AP

2005-07-05Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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