APPLICATION
NDA017802
TYPE
NDA
ORIGINAL APPROVAL
1976-03-16
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LO/OVRAL-28 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
Approval history
2002-03-06Manufacturing (CMC) · Supplement 22 · standardAP
1998-07-08Manufacturing (CMC) · Supplement 20 · standardAP
1994-11-29Labeling · Supplement 16 · standardAP
1994-01-28Labeling · Supplement 17 · standardAP
1993-12-23Manufacturing (CMC) · Supplement 15 · standardAP
1990-08-08Labeling · Supplement 13AP
1988-04-27Manufacturing (CMC) · Supplement 14 · standardAP
1986-07-15Labeling · Supplement 11AP
1986-02-19Manufacturing (CMC) · Supplement 10 · standardAP
1985-10-16Labeling · Supplement 9AP
1985-04-05Manufacturing (CMC) · Supplement 6 · standardAP
1984-09-04Manufacturing (CMC) · Supplement 8 · standardAP
1984-07-26Labeling · Supplement 7AP
1979-01-08Labeling · Supplement 2AP
1977-12-08Labeling · Supplement 3AP
1976-03-16Type 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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