APPLICATION
NDA018160
TYPE
NDA
ORIGINAL APPROVAL
1981-12-30
LATEST ACTION
1999-09-02
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEMULEN 1/35-28Discontinued
ETHINYL ESTRADIOL 0.035MG, ETHYNODIOL DIACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
Approval history
1999-09-02Labeling · Supplement 30 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 31 · standardAP
1994-04-20Labeling · Supplement 29 · standardAP
1993-04-28Labeling · Supplement 28 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 27 · standardAP
1991-11-14Labeling · Supplement 19 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 26 · standardAP
1988-10-28Manufacturing (CMC) · Supplement 22 · standardAP
1986-10-23Labeling · Supplement 17 · standardAP
1986-06-10Labeling · Supplement 16 · standardAP
1986-03-13Labeling · Supplement 15 · standardAP
1985-09-18Manufacturing (CMC) · Supplement 13 · standardAP
1985-06-03Labeling · Supplement 14 · standardAP
1985-04-05Labeling · Supplement 12 · standardAP
1985-02-12Labeling · Supplement 11 · standardAP
1984-09-18Labeling · Supplement 10 · standardAP
1984-03-06Labeling · Supplement 8 · standardAP
1983-06-09Manufacturing (CMC) · Supplement 4 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 5 · standardAP
1982-11-22Manufacturing (CMC) · Supplement 2 · standardAP
1981-12-30Type 3 - New Dosage Form · 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.
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