APPLICATION
NDA019004
TYPE
NDA
ORIGINAL APPROVAL
1984-04-04
LATEST ACTION
2002-06-03
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-NOVUM 7/14-21Discontinued
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0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
ORTHO-NOVUM 7/14-28Discontinued
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0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28
Approval history
2002-06-03Manufacturing (CMC) · Supplement 28 · standardAP
2002-02-21Manufacturing (CMC) · Supplement 27 · standardAP
2001-07-09Manufacturing (CMC) · Supplement 26 · standardAP
1998-04-28Manufacturing (CMC) · Supplement 25 · standardAP
1998-04-13Manufacturing (CMC) · Supplement 24 · standardAP
1997-02-24Manufacturing (CMC) · Supplement 22 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 23 · standardAP
1996-05-10Manufacturing (CMC) · Supplement 21 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 20 · standardAP
1995-09-07Manufacturing (CMC) · Supplement 19 · standardAP
1995-02-16Manufacturing (CMC) · Supplement 18 · standardAP
1994-06-29Labeling · Supplement 17 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 14 · standardAP
1993-11-04Manufacturing (CMC) · Supplement 16 · standardAP
1993-05-18Manufacturing (CMC) · Supplement 15 · standardAP
1991-09-23Labeling · Supplement 11 · standardAP
1991-09-16Labeling · Supplement 10 · standardAP
1991-03-18Manufacturing (CMC) · Supplement 12 · standardAP
1990-01-18Manufacturing (CMC) · Supplement 8 · standardAP
1990-01-16Manufacturing (CMC) · Supplement 9 · standardAP
1989-07-17Labeling · Supplement 2 · standardAP
1989-02-14Manufacturing (CMC) · Supplement 5 · standardAP
1989-02-14Manufacturing (CMC) · Supplement 3 · standardAP
1989-02-14Manufacturing (CMC) · Supplement 4 · standardAP
1984-04-04Type 3 - New Dosage Form · Original · 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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