FDA NDA · NDA017919

ORTHO-NOVUM 1/35-28

Sponsor: JANSSEN PHARMS

APPLICATION

NDA017919

TYPE

NDA

ORIGINAL APPROVAL

1977-06-23

LATEST ACTION

2017-08-09

ROUTE

ORAL-28

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

ORTHO-NOVUM 1/35-28 · ReferenceDiscontinued

ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2017-08-09Labeling · Supplement 100 · standard — Label ↗AP

2015-10-29Labeling · Supplement 99 · standard — Letter ↗AP

2014-09-11Manufacturing (CMC) · Supplement 98 · standardAP

2013-10-03Labeling · Supplement 86 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 96 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 92 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 90 · standard — Letter ↗AP

2012-06-18Labeling · Supplement 89 · standard — Label ↗AP

2002-06-03Manufacturing (CMC) · Supplement 75 · standardAP

2002-02-21Manufacturing (CMC) · Supplement 74 · standardAP

2001-07-09Manufacturing (CMC) · Supplement 73 · standardAP

2000-06-06Labeling · Supplement 71 · standardAP

2000-01-05Manufacturing (CMC) · Supplement 70 · standardAP

1999-08-27Labeling · Supplement 65 · standardAP

1999-08-27Labeling · Supplement 69 · standardAP

1999-01-06Labeling · Supplement 66 · standardAP

1998-04-28Manufacturing (CMC) · Supplement 68 · standardAP

1998-04-13Manufacturing (CMC) · Supplement 67 · standardAP

1997-02-24Manufacturing (CMC) · Supplement 64 · standardAP

1997-01-29Manufacturing (CMC) · Supplement 63 · standardAP

1996-05-10Manufacturing (CMC) · Supplement 61 · standardAP

1996-04-09Manufacturing (CMC) · Supplement 62 · standardAP

1995-11-30Manufacturing (CMC) · Supplement 60 · standardAP

1995-09-07Manufacturing (CMC) · Supplement 59 · standardAP

1995-02-16Manufacturing (CMC) · Supplement 58 · standardAP

1994-03-07Manufacturing (CMC) · Supplement 52 · standardAP

1994-01-04Labeling · Supplement 56 · standardAP

1993-11-04Manufacturing (CMC) · Supplement 57 · standardAP

1993-05-18Manufacturing (CMC) · Supplement 55 · standardAP

1991-09-16Labeling · Supplement 49AP

1991-03-18Manufacturing (CMC) · Supplement 50 · standardAP

1990-01-18Manufacturing (CMC) · Supplement 48 · standardAP

1989-10-23Labeling · Supplement 46AP

1989-07-19Labeling · Supplement 45AP

1988-10-28Manufacturing (CMC) · Supplement 44 · standardAP

1988-09-09Labeling · Supplement 42AP

1988-06-08Manufacturing (CMC) · Supplement 43 · standardAP

1987-11-23Manufacturing (CMC) · Supplement 40 · standardAP

1987-02-26Labeling · Supplement 41AP

1985-10-21Labeling · Supplement 38AP

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 1/35-28

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Approval history

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