APPLICATION
NDA016927
TYPE
NDA
ORIGINAL APPROVAL
1970-04-24
LATEST ACTION
1999-09-02
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEMULEN 1/50-21Discontinued
ETHINYL ESTRADIOL 0.05MG, ETHYNODIOL DIACETATE 1MG · TABLET · ORAL-21
Approval history
1999-09-02Labeling · Supplement 62 · standardAP
1994-04-20Labeling · Supplement 61 · standardAP
1993-04-28Labeling · Supplement 60 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 59 · standardAP
1991-11-14Labeling · Supplement 51 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 58 · standardAP
1988-10-28Manufacturing (CMC) · Supplement 54 · standardAP
1986-10-23Labeling · Supplement 49 · standardAP
1986-06-10Labeling · Supplement 48 · standardAP
1986-03-13Labeling · Supplement 47 · standardAP
1985-06-05Labeling · Supplement 46 · standardAP
1985-04-05Labeling · Supplement 45 · standardAP
1985-02-12Labeling · Supplement 44 · standardAP
1984-09-18Labeling · Supplement 43 · standardAP
1984-03-06Labeling · Supplement 41 · standardAP
1983-06-09Manufacturing (CMC) · Supplement 38 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 39 · standardAP
1982-11-22Manufacturing (CMC) · Supplement 36 · standardAP
1981-03-06Manufacturing (CMC) · Supplement 33 · standardAP
1970-04-24Type 4 - New Combination · 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.
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.