APPLICATION
NDA018127
TYPE
NDA
ORIGINAL APPROVAL
1978-07-05
LATEST ACTION
1998-08-10
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OVCON-35 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
Approval history
1998-08-10Labeling · Supplement 33 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 34 · standardAP
1995-07-07Manufacturing (CMC) · Supplement 32 · standardAP
1995-02-14Manufacturing (CMC) · Supplement 31 · standardAP
1995-01-25Labeling · Supplement 25AP
1995-01-25Labeling · Supplement 30 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 27 · standardAP
1993-03-12Manufacturing (CMC) · Supplement 29 · standardAP
1993-03-12Labeling · Supplement 28 · standardAP
1992-07-21Labeling · Supplement 24AP
1991-07-24Manufacturing (CMC) · Supplement 23 · standardAP
1991-03-12Manufacturing (CMC) · Supplement 22 · standardAP
1989-08-24Labeling · Supplement 20AP
1986-03-18Manufacturing (CMC) · Supplement 19 · standardAP
1984-12-03Labeling · Supplement 14AP
1984-10-01Manufacturing (CMC) · Supplement 15 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 13 · standardAP
1983-03-25Labeling · Supplement 12AP
1983-02-08Manufacturing (CMC) · Supplement 11 · standardAP
1982-11-05Manufacturing (CMC) · Supplement 10 · standardAP
1981-04-14Labeling · Supplement 8AP
1980-01-14Labeling · Supplement 5AP
1979-08-29Manufacturing (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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