APPLICATION
NDA013625
TYPE
NDA
ORIGINAL APPROVAL
1964-03-05
LATEST ACTION
2000-01-24
ROUTE
ORAL-20, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORINYLDiscontinued
MESTRANOL 0.1MG, NORETHINDRONE 2MG · TABLET · ORAL-20
NORINYL 1+50 21-DAYDiscontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-21
Approval history
2000-01-24Labeling · Supplement 181 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 180 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 179 · standardAP
1997-07-30Manufacturing (CMC) · Supplement 178 · standardAP
1995-08-30Labeling · Supplement 176 · standardAP
1994-12-13Labeling · Supplement 177 · standardAP
1994-02-04Labeling · Supplement 174AP
1992-07-31Manufacturing (CMC) · Supplement 175 · standardAP
1991-10-09Manufacturing (CMC) · Supplement 173 · standardAP
1990-11-02Labeling · Supplement 169AP
1990-09-19Manufacturing (CMC) · Supplement 172 · standardAP
1990-08-06Manufacturing (CMC) · Supplement 171 · standardAP
1986-10-22Labeling · Supplement 166AP
1986-07-17Labeling · Supplement 165AP
1985-10-25Labeling · Supplement 163AP
1985-10-25Labeling · Supplement 164AP
1985-06-19Labeling · Supplement 162AP
1985-04-16Labeling · Supplement 161AP
1984-11-13Manufacturing (CMC) · Supplement 159 · standardAP
1984-09-27Manufacturing (CMC) · Supplement 155 · standardAP
1984-07-30Labeling · Supplement 158AP
1984-06-12Labeling · Supplement 157AP
1984-05-07Labeling · Supplement 154AP
1984-03-06Labeling · Supplement 50AP
1983-07-26Manufacturing (CMC) · Supplement 49 · standardAP
1983-07-26Manufacturing (CMC) · Supplement 53 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 52 · standardAP
1983-07-19Manufacturing (CMC) · Supplement 51 · standardAP
1983-06-13Manufacturing (CMC) · Supplement 48 · standardAP
1982-09-07Manufacturing (CMC) · Supplement 42 · standardAP
1982-07-29Manufacturing (CMC) · Supplement 145 · standardAP
1982-01-11Manufacturing (CMC) · Supplement 40 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 129 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 133 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 128 · standardAP
1979-07-18Manufacturing (CMC) · Supplement 130 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 127 · standardAP
1978-11-06Manufacturing (CMC) · Supplement 126 · standardAP
1978-05-26Manufacturing (CMC) · Supplement 125 · standardAP
1977-11-22Labeling · Supplement 104AP
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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