APPLICATION
NDA016979
TYPE
NDA
ORIGINAL APPROVAL
1971-08-18
LATEST ACTION
2003-01-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEGACE · ReferenceDiscontinued
MEGESTROL ACETATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MEGACE · ReferenceDiscontinued
MEGESTROL ACETATE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-06-15Manufacturing (CMC) · Supplement 50 · standardAP
2001-01-31Labeling · Supplement 49 · standardAP
1999-11-15Labeling · Supplement 48 · standardAP
1997-09-04Labeling · Supplement 47 · standardAP
1994-06-27Labeling · Supplement 46 · standardAP
1993-08-11Manufacturing (CMC) · Supplement 45 · standardAP
1991-03-14Manufacturing (CMC) · Supplement 44 · standardAP
1991-03-04Manufacturing (CMC) · Supplement 42 · standardAP
1990-12-11Labeling · Supplement 25 · standardAP
1990-09-06Manufacturing (CMC) · Supplement 30 · standardAP
1989-08-11Manufacturing (CMC) · Supplement 41 · standardAP
1989-08-08Labeling · Supplement 40 · standardAP
1989-01-26Manufacturing (CMC) · Supplement 39 · standardAP
1988-06-20Manufacturing (CMC) · Supplement 36 · standardAP
1988-04-12Manufacturing (CMC) · Supplement 38 · standardAP
1988-03-07Manufacturing (CMC) · Supplement 37 · standardAP
1987-11-13Labeling · Supplement 31 · standardAP
1985-11-25Labeling · Supplement 33 · standardAP
1985-07-23Manufacturing (CMC) · Supplement 29 · standardAP
1984-12-11Manufacturing (CMC) · Supplement 28 · standardAP
1984-10-16Manufacturing (CMC) · Supplement 26 · standardAP
1984-07-10Manufacturing (CMC) · Supplement 22 · standardAP
1984-05-24Manufacturing (CMC) · Supplement 23 · standardAP
1983-02-22Manufacturing (CMC) · Supplement 19 · standardAP
1982-11-19Manufacturing (CMC) · Supplement 24 · standardAP
1982-02-10Manufacturing (CMC) · Supplement 20 · standardAP
1981-03-11Labeling · Supplement 18 · standardAP
1980-02-26Labeling · Supplement 16 · standardAP
1979-06-20Manufacturing (CMC) · Supplement 15 · standardAP
1979-03-29Manufacturing (CMC) · Supplement 17 · standardAP
1977-06-15Labeling · Supplement 14 · standardAP
1976-11-23Manufacturing (CMC) · Supplement 13 · standardAP
1976-11-23Manufacturing (CMC) · Supplement 12 · standardAP
1976-09-21Manufacturing (CMC) · Supplement 11 · standardAP
1976-07-16Labeling · Supplement 10 · standardAP
1976-07-07Manufacturing (CMC) · Supplement 9 · standardAP
1975-06-03REMS · Supplement 8 · standardAP
1971-08-18Type 1 - New Molecular Entity · Original · standardAP
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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