FDA NDA · NDA017735

MODICON 28

Sponsor: JANSSEN PHARMS

APPLICATION

NDA017735

TYPE

NDA

ORIGINAL APPROVAL

1976-05-14

LATEST ACTION

2017-08-09

ROUTE

ORAL-28

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

MODICON 28 · ReferenceDiscontinued

ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2017-08-09Labeling · Supplement 118 · standard — Label ↗AP

2015-10-29Labeling · Supplement 117 · standard — Letter ↗AP

2014-09-11Manufacturing (CMC) · Supplement 116 · standardAP

2013-10-03Labeling · Supplement 104 · standard — Label ↗AP

2013-10-02Labeling · Supplement 108 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 114 · standard — Letter ↗AP

2013-10-02Labeling · Supplement 110 · standard — Letter ↗AP

2012-06-18Labeling · Supplement 107 · standard — Letter ↗AP

2002-06-03Manufacturing (CMC) · Supplement 93 · standardAP

2002-02-21Manufacturing (CMC) · Supplement 92 · standardAP

2001-07-09Manufacturing (CMC) · Supplement 91 · standardAP

2000-06-06Labeling · Supplement 89 · standardAP

2000-01-05Manufacturing (CMC) · Supplement 88 · standardAP

1999-08-27Labeling · Supplement 87 · standardAP

1999-08-27Labeling · Supplement 83 · standardAP

1999-01-06Labeling · Supplement 84 · standardAP

1998-04-28Manufacturing (CMC) · Supplement 86 · standardAP

1998-04-13Manufacturing (CMC) · Supplement 85 · standardAP

1997-02-24Manufacturing (CMC) · Supplement 82 · standardAP

1997-01-29Manufacturing (CMC) · Supplement 81 · standardAP

1996-05-10Manufacturing (CMC) · Supplement 79 · standardAP

1996-04-09Manufacturing (CMC) · Supplement 80 · standardAP

1995-11-30Manufacturing (CMC) · Supplement 78 · standardAP

1995-09-07Manufacturing (CMC) · Supplement 77 · standardAP

1995-02-16Manufacturing (CMC) · Supplement 76 · standardAP

1994-03-07Manufacturing (CMC) · Supplement 72 · standardAP

1994-01-04Labeling · Supplement 74 · standardAP

1993-11-04Manufacturing (CMC) · Supplement 75 · standardAP

1993-05-18Manufacturing (CMC) · Supplement 73 · standardAP

1991-09-16Labeling · Supplement 69AP

1991-03-18Manufacturing (CMC) · Supplement 70 · standardAP

1990-01-18Manufacturing (CMC) · Supplement 68 · standardAP

1989-10-23Labeling · Supplement 66AP

1989-07-19Labeling · Supplement 65AP

1988-10-28Manufacturing (CMC) · Supplement 64 · standardAP

1988-09-08Labeling · Supplement 62AP

1988-06-08Manufacturing (CMC) · Supplement 63 · standardAP

1987-11-23Manufacturing (CMC) · Supplement 60 · standardAP

1987-02-26Labeling · Supplement 61AP

1985-10-21Labeling · Supplement 58AP

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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MODICON 28

Products

Approval history

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