APPLICATION
ANDA072723
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-30
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KELNOR 1/50Discontinued
ETHINYL ESTRADIOL 0.05MG, ETHYNODIOL DIACETATE 1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 44 · standardAP
2017-09-01Labeling · Supplement 38 · standardAP
2017-08-07Labeling · Supplement 37 · standardAP
2004-10-20Labeling · Supplement 15AP
2002-10-18Manufacturing (CMC) · Supplement 9AP
2002-09-11Labeling · Supplement 5AP
2002-07-30Manufacturing (CMC) · Supplement 10AP
2001-10-09Manufacturing (CMC) · Supplement 8AP
2001-01-29Manufacturing (CMC) · Supplement 6AP
1997-04-30Labeling · Supplement 4AP
1996-04-10Labeling · Supplement 3AP
1994-09-27Labeling · Supplement 2AP
1993-08-12Labeling · Supplement 1AP
1991-12-30OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.