APPLICATION
NDA017716
TYPE
NDA
ORIGINAL APPROVAL
1976-03-29
LATEST ACTION
1998-12-21
ROUTE
ORAL-28
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ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
Approval history
1998-12-21Manufacturing (CMC) · Supplement 47 · standardAP
1998-08-10Labeling · Supplement 45 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 46 · standardAP
1995-07-07Manufacturing (CMC) · Supplement 44 · standardAP
1995-02-14Labeling · Supplement 38AP
1995-01-25Labeling · Supplement 43 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 41 · standardAP
1993-03-12Labeling · Supplement 39AP
1993-03-12Manufacturing (CMC) · Supplement 42 · standardAP
1992-07-21Labeling · Supplement 37AP
1991-07-24Manufacturing (CMC) · Supplement 36 · standardAP
1991-03-12Manufacturing (CMC) · Supplement 35 · standardAP
1989-08-24Labeling · Supplement 33AP
1986-03-18Manufacturing (CMC) · Supplement 32 · standardAP
1984-12-03Labeling · Supplement 28AP
1984-09-27Manufacturing (CMC) · Supplement 29 · standardAP
1984-02-08Manufacturing (CMC) · Supplement 25 · standardAP
1984-01-23Manufacturing (CMC) · Supplement 27 · standardAP
1983-03-25Labeling · Supplement 26AP
1982-11-05Manufacturing (CMC) · Supplement 24 · standardAP
1981-04-14Labeling · Supplement 22AP
1980-01-14Labeling · Supplement 19AP
1979-08-28Manufacturing (CMC) · Supplement 18 · standardAP
1979-06-04Labeling · Supplement 17AP
1979-01-19Labeling · Supplement 15AP
1978-10-20Manufacturing (CMC) · Supplement 14 · standardAP
1978-10-18Manufacturing (CMC) · Supplement 11 · standardAP
1978-10-18Manufacturing (CMC) · Supplement 10 · standardAP
1978-07-14Labeling · Supplement 8AP
1978-07-14Labeling · Supplement 12AP
1978-06-08Manufacturing (CMC) · Supplement 13 · standardAP
1978-04-28Labeling · Supplement 6AP
1978-04-28Labeling · Supplement 9AP
1976-04-30Labeling · Supplement 1AP
1976-03-29Type 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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