APPLICATION
NDA016936
TYPE
NDA
ORIGINAL APPROVAL
1970-12-08
LATEST ACTION
1996-12-27
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEMULEN 1/50-28Discontinued
ETHINYL ESTRADIOL 0.05MG, ETHYNODIOL DIACETATE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
Approval history
1996-12-27Manufacturing (CMC) · Supplement 42 · standardAP
1994-04-20Labeling · Supplement 40 · standardAP
1993-04-28Labeling · Supplement 39 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 38 · standardAP
1991-11-14Labeling · Supplement 30 · standardAP
1991-08-07Manufacturing (CMC) · Supplement 37 · standardAP
1988-10-28Manufacturing (CMC) · Supplement 33 · standardAP
1986-10-23Labeling · Supplement 28 · standardAP
1986-06-10Labeling · Supplement 27 · standardAP
1986-03-13Labeling · Supplement 26 · standardAP
1985-06-05Labeling · Supplement 25 · standardAP
1985-04-05Labeling · Supplement 24 · standardAP
1985-02-12Labeling · Supplement 23 · standardAP
1984-09-18Labeling · Supplement 22 · standardAP
1984-03-06Labeling · Supplement 20 · standardAP
1981-03-03Labeling · Supplement 15 · standardAP
1970-12-08Type 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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