FDA NDA · NDA017577

DITROPAN

Sponsor: JANSSEN PHARMS

APPLICATION

NDA017577

TYPE

NDA

ORIGINAL APPROVAL

1975-07-16

LATEST ACTION

2012-03-22

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

DITROPAN · ReferenceDiscontinued

OXYBUTYNIN CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2012-03-22Labeling · Supplement 38 · standard — Letter ↗AP

2011-12-15Labeling · Supplement 37 · standard — Label ↗AP

2011-08-08Labeling · Supplement 36 · standard — Label ↗AP

2009-07-13Labeling · Supplement 35 · standard — Letter ↗AP

2008-02-06Labeling · Supplement 34 · standard — Label ↗AP

2003-04-15Efficacy · Supplement 33 · standard — Label ↗AP

2003-04-15Efficacy · Supplement 32 · standard — Review ↗AP

1998-02-20Manufacturing (CMC) · Supplement 30 · standardAP

1997-11-13Manufacturing (CMC) · Supplement 29 · standardAP

1996-07-09Manufacturing (CMC) · Supplement 28 · standardAP

1996-05-31Manufacturing (CMC) · Supplement 26 · standardAP

1991-12-26Manufacturing (CMC) · Supplement 25 · standardAP

1991-03-19Labeling · Supplement 24 · standardAP

1990-11-27Manufacturing (CMC) · Supplement 23 · standardAP

1989-02-10Labeling · Supplement 21 · standardAP

1988-04-29Manufacturing (CMC) · Supplement 20 · standardAP

1988-02-25Labeling · Supplement 19 · standardAP

1986-10-23Manufacturing (CMC) · Supplement 18 · standardAP

1986-08-08Manufacturing (CMC) · Supplement 17 · standardAP

1986-06-11Labeling · Supplement 16 · standardAP

1985-06-19Manufacturing (CMC) · Supplement 15 · standardAP

1983-01-07Manufacturing (CMC) · Supplement 12 · standardAP

1983-01-07Manufacturing (CMC) · Supplement 13 · standardAP

1983-01-07Manufacturing (CMC) · Supplement 11 · standardAP

1982-09-20Labeling · Supplement 10 · standardAP

1980-12-22Manufacturing (CMC) · Supplement 9 · standardAP

1979-06-25Labeling · Supplement 8 · standardAP

1977-12-05Manufacturing (CMC) · Supplement 7 · standardAP

1977-04-01Manufacturing (CMC) · Supplement 5 · standardAP

1977-03-01Manufacturing (CMC) · Supplement 3 · standardAP

1976-10-21Labeling · Supplement 4 · standardAP

1976-04-16Labeling · Supplement 1 · standardAP

1976-04-02Manufacturing (CMC) · Supplement 2 · standardAP

1975-07-16Type 1 - New Molecular Entity · Original · standardAP

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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Approval history

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