APPLICATION
ANDA072423
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-08
LATEST ACTION
2004-08-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEGESTROL ACETATEPrescription
MEGESTROL ACETATE 40MG · TABLET · ORAL
Approval history
2004-08-06Labeling · Supplement 17AP
2003-08-29Labeling · Supplement 16AP
2001-12-12Labeling · Supplement 15AP
2001-10-11Manufacturing (CMC) · Supplement 13AP
2001-10-11Labeling · Supplement 14AP
2000-10-13Labeling · Supplement 12AP
2000-06-27Labeling · Supplement 11AP
1999-10-29Manufacturing (CMC) · Supplement 9AP
1999-10-29Labeling · Supplement 10AP
1999-05-19Labeling · Supplement 8AP
1999-02-19Labeling · Supplement 7AP
1998-08-31Labeling · Supplement 6AP
1997-11-26Manufacturing (CMC) · Supplement 5AP
1997-11-26Manufacturing (CMC) · Supplement 4AP
1992-03-04Labeling · Supplement 3AP
1991-07-02Labeling · Supplement 2AP
1989-08-01Labeling · Supplement 1AP
1988-08-08OriginalAP
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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