APPLICATION
ANDA084948
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-28
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MENESTDiscontinued
ESTROGENS, ESTERIFIED 0.625MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 24 · standardAP
2019-04-08Labeling · Supplement 23 · standardAP
2006-02-07Labeling · Supplement 17AP
2004-12-01Labeling · Supplement 19AP
2000-04-28Manufacturing (CMC) · Supplement 13AP
1999-03-22Manufacturing (CMC) · Supplement 12AP
1994-07-18Manufacturing (CMC) · Supplement 11AP
1992-04-13Labeling · Supplement 10AP
1990-03-28Labeling · Supplement 9AP
1982-06-21Manufacturing (CMC) · Supplement 3AP
1977-09-28OriginalAP
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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