APPLICATION
NDA018354
TYPE
NDA
ORIGINAL APPROVAL
1982-01-11
LATEST ACTION
2009-03-13
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-NOVUM 10/11-28 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG · TABLET · ORAL-28
ORTHO-NOVUM 10/11-21 · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
Approval history
2009-03-13Labeling · Supplement 10AP
2009-03-13Labeling · Supplement 1AP
2009-03-13Labeling · Supplement 40 · standardAP
2002-06-03Manufacturing (CMC) · Supplement 43 · standardAP
2002-02-21Manufacturing (CMC) · Supplement 42 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 41 · standardAP
2000-01-21Labeling · Supplement 38 · standardAP
2000-01-05Manufacturing (CMC) · Supplement 39 · standardAP
1999-08-27Labeling · Supplement 37 · standardAP
1999-08-27Labeling · Supplement 34 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 36 · standardAP
1998-04-13Manufacturing (CMC) · Supplement 35 · standardAP
1997-02-24Manufacturing (CMC) · Supplement 32 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 33 · standardAP
1996-05-10Manufacturing (CMC) · Supplement 30 · standardAP
1996-04-09Manufacturing (CMC) · Supplement 31 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 29 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 28 · standardAP
1995-02-16Manufacturing (CMC) · Supplement 27 · standardAP
1994-07-06Labeling · Supplement 26 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 23 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 25 · standardAP
1993-05-18Manufacturing (CMC) · Supplement 24 · standardAP
1991-09-16Labeling · Supplement 20AP
1991-03-18Manufacturing (CMC) · Supplement 21 · standardAP
1990-01-18Manufacturing (CMC) · Supplement 19 · standardAP
1989-10-23Labeling · Supplement 17AP
1989-07-19Labeling · Supplement 16AP
1988-10-28Manufacturing (CMC) · Supplement 15 · standardAP
1988-09-09Labeling · Supplement 13AP
1988-06-08Manufacturing (CMC) · Supplement 14 · standardAP
1987-11-23Manufacturing (CMC) · Supplement 11 · standardAP
1987-02-26Labeling · Supplement 12AP
1985-10-21Labeling · Supplement 9AP
1985-04-05Labeling · Supplement 8AP
1984-06-21Labeling · Supplement 7AP
1984-01-30Labeling · Supplement 6AP
1983-09-29Labeling · Supplement 5AP
1983-06-15Labeling · Supplement 3AP
1983-06-09Manufacturing (CMC) · Supplement 2 · 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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