APPLICATION
NDA017031
TYPE
NDA
ORIGINAL APPROVAL
1973-10-23
LATEST ACTION
2025-09-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
OPILL · ReferenceOver-the-counter
NORGESTREL 0.075MG · TABLET · ORAL
Approval history
2002-03-06Manufacturing (CMC) · Supplement 31 · standardAP
1998-07-08Manufacturing (CMC) · Supplement 30 · standardAP
1996-01-18Labeling · Supplement 27 · standardAP
1994-11-29Labeling · Supplement 26 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 25 · standardAP
1992-08-19Labeling · Supplement 24AP
1988-10-06Manufacturing (CMC) · Supplement 23 · standardAP
1988-09-01Manufacturing (CMC) · Supplement 22 · standardAP
1987-04-07Manufacturing (CMC) · Supplement 20 · standardAP
1985-10-16Labeling · Supplement 19AP
1984-05-03Labeling · Supplement 18AP
1983-12-22Labeling · Supplement 17AP
1982-06-03Manufacturing (CMC) · Supplement 15 · standardAP
1980-04-15Manufacturing (CMC) · Supplement 11 · standardAP
1978-11-20Labeling · Supplement 7AP
1977-12-08Labeling · Supplement 4AP
1977-08-15Manufacturing (CMC) · Supplement 6 · standardAP
1976-12-01Manufacturing (CMC) · Supplement 3 · standardAP
1976-01-15Manufacturing (CMC) · Supplement 2 · standardAP
1973-10-23Type 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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