APPLICATION
ANDA074621
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-30
LATEST ACTION
2010-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEGESTROL ACETATEPrescription
MEGESTROL ACETATE 40MG · TABLET · ORAL
MEGESTROL ACETATEPrescription
MEGESTROL ACETATE 20MG · TABLET · ORAL
Approval history
2010-07-29Manufacturing (CMC) · Supplement 23AP
2002-03-18Manufacturing (CMC) · Supplement 19AP
2002-03-12Manufacturing (CMC) · Supplement 18AP
2002-01-31Manufacturing (CMC) · Supplement 16AP
2002-01-31Manufacturing (CMC) · Supplement 15AP
2001-08-14Labeling · Supplement 17AP
2000-06-05Labeling · Supplement 14AP
1999-12-21Manufacturing (CMC) · Supplement 13AP
1999-05-20Manufacturing (CMC) · Supplement 12AP
1998-12-01Manufacturing (CMC) · Supplement 10AP
1998-11-25Labeling · Supplement 11AP
1998-08-24Labeling · Supplement 8AP
1998-08-17Manufacturing (CMC) · Supplement 9AP
1998-03-17Manufacturing (CMC) · Supplement 7AP
1997-12-08Manufacturing (CMC) · Supplement 6AP
1996-08-16Manufacturing (CMC) · Supplement 4AP
1996-08-16Labeling · Supplement 2AP
1996-08-16Manufacturing (CMC) · Supplement 5AP
1996-08-16Manufacturing (CMC) · Supplement 3AP
1996-08-16Manufacturing (CMC) · Supplement 1AP
1995-11-30OriginalAP
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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