APPLICATION
NDA016709
TYPE
NDA
ORIGINAL APPROVAL
1968-08-21
LATEST ACTION
2002-06-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-NOVUM 1/50 28Discontinued
MESTRANOL 0.05MG, NORETHINDRONE 1MG · TABLET · ORAL-28
Approval history
2002-06-03Manufacturing (CMC) · Supplement 128 · standardAP
2000-06-05Labeling · Supplement 126 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 125 · standardAP
1998-07-10Labeling · Supplement 123 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 124 · standardAP
1997-11-28Labeling · Supplement 122 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 121 · standardAP
1996-12-27Manufacturing (CMC) · Supplement 107 · standardAP
1996-04-09Manufacturing (CMC) · Supplement 120 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 118 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 117 · standardAP
1994-12-07Manufacturing (CMC) · Supplement 116 · standardAP
1994-07-06Labeling · Supplement 115 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 112 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 114 · standardAP
1993-05-18Manufacturing (CMC) · Supplement 113 · standardAP
1991-09-16Labeling · Supplement 109AP
1991-03-18Manufacturing (CMC) · Supplement 110 · standardAP
1990-01-18Manufacturing (CMC) · Supplement 108 · standardAP
1989-10-23Labeling · Supplement 106AP
1989-07-19Labeling · Supplement 105AP
1988-10-28Manufacturing (CMC) · Supplement 104 · standardAP
1988-09-09Labeling · Supplement 102AP
1988-06-08Manufacturing (CMC) · Supplement 103 · standardAP
1987-11-23Manufacturing (CMC) · Supplement 100 · standardAP
1987-02-26Labeling · Supplement 101AP
1985-10-21Labeling · Supplement 98AP
1985-04-05Labeling · Supplement 97AP
1984-06-21Labeling · Supplement 96AP
1984-01-30Labeling · Supplement 95AP
1983-09-29Labeling · Supplement 94AP
1979-11-08Manufacturing (CMC) · Supplement 84 · standardAP
1979-10-19Manufacturing (CMC) · Supplement 80 · standardAP
1979-08-15Labeling · Supplement 81AP
1979-04-10Labeling · Supplement 49AP
1978-07-25Manufacturing (CMC) · Supplement 77 · standardAP
1978-07-25Manufacturing (CMC) · Supplement 53 · standardAP
1978-06-26Labeling · Supplement 76AP
1978-05-25Manufacturing (CMC) · Supplement 60 · standardAP
1978-04-17Manufacturing (CMC) · Supplement 63 · 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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