APPLICATION
NDA017489
TYPE
NDA
ORIGINAL APPROVAL
1974-10-15
LATEST ACTION
2002-02-21
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-NOVUM 1/35-21Discontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
Approval history
2002-02-21Manufacturing (CMC) · Supplement 91 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 90 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 88 · standardAP
1999-08-27Labeling · Supplement 84 · standardAP
1999-08-27Labeling · Supplement 87 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 86 · standardAP
1998-04-13Manufacturing (CMC) · Supplement 85 · standardAP
1997-02-24Manufacturing (CMC) · Supplement 83 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 82 · standardAP
1996-05-10Manufacturing (CMC) · Supplement 80 · standardAP
1996-04-09Manufacturing (CMC) · Supplement 81 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 79 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 78 · standardAP
1995-02-16Manufacturing (CMC) · Supplement 77 · standardAP
1994-06-28Labeling · Supplement 76 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 73 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 75 · standardAP
1993-05-18Manufacturing (CMC) · Supplement 74 · standardAP
1991-09-16Labeling · Supplement 70 · standardAP
1991-03-18Manufacturing (CMC) · Supplement 71 · standardAP
1989-10-23Labeling · Supplement 68 · standardAP
1989-07-19Labeling · Supplement 67 · standardAP
1988-10-28Manufacturing (CMC) · Supplement 66 · standardAP
1988-09-08Labeling · Supplement 64 · standardAP
1988-06-08Manufacturing (CMC) · Supplement 65 · standardAP
1987-11-23Manufacturing (CMC) · Supplement 62 · standardAP
1987-02-26Labeling · Supplement 63 · standardAP
1985-10-21Labeling · Supplement 60 · standardAP
1985-04-05Labeling · Supplement 59 · standardAP
1984-06-21Labeling · Supplement 58 · standardAP
1984-01-30Labeling · Supplement 57 · standardAP
1983-09-29Labeling · Supplement 56 · standardAP
1983-06-15Labeling · Supplement 54 · standardAP
1983-06-09Manufacturing (CMC) · Supplement 53 · standardAP
1980-11-20Manufacturing (CMC) · Supplement 48 · standardAP
1980-11-20Manufacturing (CMC) · Supplement 49 · standardAP
1980-08-21Manufacturing (CMC) · Supplement 46 · standardAP
1980-03-24Manufacturing (CMC) · Supplement 45 · standardAP
1980-03-24Manufacturing (CMC) · Supplement 35 · standardAP
1979-12-05Labeling · Supplement 44 · 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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