APPLICATION
NDA017576
TYPE
NDA
ORIGINAL APPROVAL
1975-08-28
LATEST ACTION
2008-07-22
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OVCON-50Discontinued
ETHINYL ESTRADIOL 0.05MG, NORETHINDRONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28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 48 · standardAP
1998-08-10Labeling · Supplement 45 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 47 · standardAP
1997-06-05Labeling · Supplement 46 · standardAP
1995-07-07Manufacturing (CMC) · Supplement 44 · standardAP
1995-02-14Manufacturing (CMC) · Supplement 43 · standardAP
1995-01-25Labeling · Supplement 42 · standardAP
1994-05-24Manufacturing (CMC) · Supplement 39 · standardAP
1993-03-12Labeling · Supplement 40 · standardAP
1993-03-12Manufacturing (CMC) · Supplement 41 · standardAP
1992-07-21Labeling · Supplement 37AP
1991-01-02Manufacturing (CMC) · Supplement 35 · standardAP
1989-08-24Labeling · Supplement 33AP
1986-03-18Manufacturing (CMC) · Supplement 32 · standardAP
1986-01-10Manufacturing (CMC) · Supplement 30 · standardAP
1984-12-03Labeling · Supplement 26AP
1984-09-27Manufacturing (CMC) · Supplement 27 · standardAP
1984-02-08Manufacturing (CMC) · Supplement 24 · standardAP
1983-03-25Labeling · Supplement 25AP
1981-04-14Labeling · Supplement 21AP
1980-01-22Labeling · Supplement 18AP
1979-07-31Manufacturing (CMC) · Supplement 17 · standardAP
1979-06-04Labeling · Supplement 16AP
1979-03-12Manufacturing (CMC) · Supplement 9 · standardAP
1979-01-23Labeling · Supplement 14AP
1978-10-20Manufacturing (CMC) · Supplement 13 · standardAP
1978-10-18Manufacturing (CMC) · Supplement 10 · standardAP
1978-07-14Labeling · Supplement 11AP
1978-07-14Labeling · Supplement 7AP
1978-06-08Manufacturing (CMC) · Supplement 12 · standardAP
1978-04-28Labeling · Supplement 8AP
1978-04-28Labeling · Supplement 6AP
1976-05-03Labeling · Supplement 1AP
1975-08-28Type 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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