FDA NDA · NDA018985

ORTHO-NOVUM 7/7/7-28

Sponsor: JANSSEN PHARMS

APPLICATION

NDA018985

TYPE

NDA

ORIGINAL APPROVAL

1984-04-04

LATEST ACTION

2017-08-09

ROUTE

ORAL-28, ORAL-21

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

ORTHO-NOVUM 7/7/7-28 · ReferenceDiscontinued

ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

ORTHO-NOVUM 7/7/7-21Discontinued

ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-21

Approval history

2017-08-09Labeling · Supplement 64 · standard — Label ↗AP

2015-10-29Labeling · Supplement 63 · standard — Label ↗AP

2014-09-11Manufacturing (CMC) · Supplement 62 · standardAP

2013-10-03Labeling · Supplement 50 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 60 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 56 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 54 · standard — Letter ↗AP

2012-06-18Labeling · Supplement 53 · standard — Label ↗AP

2002-06-03Manufacturing (CMC) · Supplement 39 · standardAP

2002-02-21Manufacturing (CMC) · Supplement 38 · standardAP

2001-07-09Manufacturing (CMC) · Supplement 37 · standardAP

2000-06-06Labeling · Supplement 35 · standardAP

2000-01-05Manufacturing (CMC) · Supplement 34 · standardAP

1999-08-27Labeling · Supplement 30 · standardAP

1999-08-27Labeling · Supplement 29 · standardAP

1999-08-27Labeling · Supplement 33 · standardAP

1998-04-28Manufacturing (CMC) · Supplement 32 · standardAP

1998-04-13Manufacturing (CMC) · Supplement 31 · standardAP

1997-02-24Manufacturing (CMC) · Supplement 28 · standardAP

1997-01-29Manufacturing (CMC) · Supplement 27 · standardAP

1996-05-10Manufacturing (CMC) · Supplement 25 · standardAP

1996-04-09Manufacturing (CMC) · Supplement 26 · standardAP

1995-11-30Manufacturing (CMC) · Supplement 24 · standardAP

1995-09-07Manufacturing (CMC) · Supplement 23 · standardAP

1995-02-16Manufacturing (CMC) · Supplement 22 · standardAP

1994-03-07Manufacturing (CMC) · Supplement 17 · standardAP

1994-01-03Labeling · Supplement 20 · standardAP

1993-11-04Manufacturing (CMC) · Supplement 21 · standardAP

1993-05-18Manufacturing (CMC) · Supplement 19 · standardAP

1991-09-16Labeling · Supplement 14AP

1991-03-18Manufacturing (CMC) · Supplement 15 · standardAP

1990-01-18Manufacturing (CMC) · Supplement 13 · standardAP

1989-10-23Labeling · Supplement 11AP

1989-07-19Labeling · Supplement 10AP

1988-10-28Manufacturing (CMC) · Supplement 9 · standardAP

1988-09-09Labeling · Supplement 7AP

1988-06-08Manufacturing (CMC) · Supplement 8 · standardAP

1987-11-23Manufacturing (CMC) · Supplement 5 · standardAP

1987-02-02Labeling · Supplement 6AP

1985-10-21Labeling · Supplement 3AP

VIEW ON DRUGS@FDA ↗

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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ORTHO-NOVUM 7/7/7-28

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Approval history

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