APPLICATION
NDA017612
TYPE
NDA
ORIGINAL APPROVAL
1975-03-17
LATEST ACTION
2022-10-31
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LO/OVRAL · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.03MG, NORGESTREL 0.3MG · TABLET · ORAL-21
Approval history
2002-03-06Manufacturing (CMC) · Supplement 35 · priorityAP
1998-07-08Manufacturing (CMC) · Supplement 33 · priorityAP
1994-11-29Labeling · Supplement 30 · standardAP
1994-01-28Labeling · Supplement 29 · standardAP
1993-12-23Manufacturing (CMC) · Supplement 28 · priorityAP
1990-08-08Labeling · Supplement 25AP
1989-04-18Manufacturing (CMC) · Supplement 27 · priorityAP
1988-10-19Manufacturing (CMC) · Supplement 18 · priorityAP
1988-04-27Manufacturing (CMC) · Supplement 26 · priorityAP
1986-07-15Labeling · Supplement 22AP
1986-02-19Manufacturing (CMC) · Supplement 21 · priorityAP
1986-01-07Manufacturing (CMC) · Supplement 19 · priorityAP
1985-10-16Labeling · Supplement 20AP
1985-02-19Manufacturing (CMC) · Supplement 16 · priorityAP
1984-07-26Labeling · Supplement 17AP
1984-01-13Labeling · Supplement 15AP
1980-02-28Manufacturing (CMC) · Supplement 11 · priorityAP
1978-11-20Labeling · Supplement 6AP
1977-11-22Labeling · Supplement 9AP
1975-03-17Type 3 - New Dosage Form · Original · priorityAP
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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