APPLICATION
NDA012728
TYPE
NDA
ORIGINAL APPROVAL
1962-05-21
LATEST ACTION
2000-01-05
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-NOVUM 1/50 21Discontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-21
ORTHO-NOVUM 2-21Discontinued
MESTRANOL 0.1MG, NORETHINDRONE 2MG · TABLET · ORAL-21
ORTHO-NOVUM 10-21Discontinued
MESTRANOL 0.06MG, NORETHINDRONE 10MG · TABLET · ORAL-21
Approval history
2000-01-05Manufacturing (CMC) · Supplement 190 · standardAP
1998-07-10Labeling · Supplement 188 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 189 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 186 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 173 · standardAP
1996-04-09Manufacturing (CMC) · Supplement 185 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 183 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 182 · standardAP
1994-12-07Manufacturing (CMC) · Supplement 181 · standardAP
1994-06-28Labeling · Supplement 180 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 177 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 179 · standardAP
1993-05-18Manufacturing (CMC) · Supplement 178 · standardAP
1991-09-16Labeling · Supplement 174 · standardAP
1991-03-18Manufacturing (CMC) · Supplement 175 · standardAP
1989-10-23Labeling · Supplement 172 · standardAP
1989-07-19Labeling · Supplement 171 · standardAP
1988-10-28Manufacturing (CMC) · Supplement 170 · standardAP
1988-09-09Labeling · Supplement 166 · standardAP
1988-06-08Manufacturing (CMC) · Supplement 169 · standardAP
1987-11-23Manufacturing (CMC) · Supplement 164 · standardAP
1987-02-26Labeling · Supplement 165 · standardAP
1985-10-21Labeling · Supplement 162 · standardAP
1985-04-05Labeling · Supplement 161 · standardAP
1984-06-21Labeling · Supplement 160 · standardAP
1984-01-30Labeling · Supplement 159 · standardAP
1983-09-29Labeling · Supplement 158 · standardAP
1978-09-14Labeling · Supplement 105 · standardAP
1978-07-25Manufacturing (CMC) · Supplement 86 · standardAP
1978-03-29REMS · Supplement 87 · standardAP
1977-10-20Labeling · Supplement 85 · standardAP
1977-07-01Labeling · Supplement 84 · standardAP
1976-08-06Manufacturing (CMC) · Supplement 72 · standardAP
1976-08-06Manufacturing (CMC) · Supplement 73 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 64 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 62 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 60 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 59 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 63 · standardAP
1975-08-07Manufacturing (CMC) · Supplement 61 · 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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