APPLICATION
NDA018128
TYPE
NDA
ORIGINAL APPROVAL
1978-07-05
LATEST ACTION
1997-11-14
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OVCON-50Discontinued
ETHINYL ESTRADIOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-21
Approval history
1997-11-14Manufacturing (CMC) · Supplement 29 · standardAP
1995-01-25Labeling · Supplement 27 · standardAP
1994-05-24Manufacturing (CMC) · Supplement 24 · standardAP
1993-03-12Manufacturing (CMC) · Supplement 26 · standardAP
1993-03-12Labeling · Supplement 25 · standardAP
1992-07-21Labeling · Supplement 23AP
1991-01-02Manufacturing (CMC) · Supplement 21 · standardAP
1989-08-24Labeling · Supplement 19AP
1986-03-18Manufacturing (CMC) · Supplement 18 · standardAP
1986-01-10Manufacturing (CMC) · Supplement 16 · standardAP
1984-12-03Labeling · Supplement 12AP
1984-10-01Manufacturing (CMC) · Supplement 13 · standardAP
1984-02-08Manufacturing (CMC) · Supplement 10 · standardAP
1983-03-25Labeling · Supplement 11AP
1981-04-14Labeling · Supplement 8AP
1980-01-22Labeling · Supplement 5AP
1979-07-31Manufacturing (CMC) · Supplement 4 · standardAP
1979-06-04Labeling · Supplement 3AP
1979-01-19Labeling · Supplement 1AP
1978-07-05Type 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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