APPLICATION
NDA017355
TYPE
NDA
ORIGINAL APPROVAL
1973-04-30
LATEST ACTION
2023-01-04
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOESTRIN FE 1.5/30 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21
Approval history
2014-08-05Manufacturing (CMC) · Supplement 48 · priorityAP
1999-11-24Labeling · Supplement 44 · standardAP
1999-03-31Labeling · Supplement 45 · standardAP
1999-01-08Labeling · Supplement 43 · standardAP
1998-01-16Labeling · Supplement 42 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 41 · priorityAP
1997-07-28Manufacturing (CMC) · Supplement 40 · priorityAP
1997-07-28Manufacturing (CMC) · Supplement 39 · priorityAP
1996-03-08Labeling · Supplement 34 · standardAP
1996-03-08Labeling · Supplement 32AP
1995-07-07Manufacturing (CMC) · Supplement 38 · priorityAP
1994-06-27Manufacturing (CMC) · Supplement 36 · priorityAP
1994-06-02Manufacturing (CMC) · Supplement 37 · priorityAP
1994-03-07Manufacturing (CMC) · Supplement 35 · priorityAP
1993-07-09Manufacturing (CMC) · Supplement 33 · priorityAP
1991-04-22Manufacturing (CMC) · Supplement 31 · priorityAP
1989-05-17Manufacturing (CMC) · Supplement 30 · priorityAP
1988-09-13Labeling · Supplement 28AP
1988-03-16Manufacturing (CMC) · Supplement 29 · priorityAP
1986-10-22Manufacturing (CMC) · Supplement 26 · priorityAP
1986-10-22Labeling · Supplement 27AP
1986-06-04Labeling · Supplement 25AP
1985-09-17Manufacturing (CMC) · Supplement 23 · priorityAP
1984-10-22Labeling · Supplement 24AP
1982-11-18Manufacturing (CMC) · Supplement 22 · priorityAP
1981-11-09Manufacturing (CMC) · Supplement 21 · priorityAP
1981-04-06Labeling · Supplement 20AP
1977-02-08Manufacturing (CMC) · Supplement 15 · priorityAP
1977-02-08Manufacturing (CMC) · Supplement 16 · priorityAP
1975-11-14Labeling · Supplement 12AP
1973-04-30Type 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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