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FDA NDA · NDA018211

DITROPAN

Sponsor: ORTHO MCNEIL JANSSEN

APPLICATION
NDA018211
TYPE
NDA
ORIGINAL APPROVAL
1979-11-29
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

DITROPAN · ReferenceDiscontinued
OXYBUTYNIN CHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2009-03-13Labeling · Supplement 2AP
2008-02-06Labeling · Supplement 17 · standard — Letter ↗AP
2003-04-15Efficacy · Supplement 16 · standard — Review ↗AP
2003-04-15Labeling · Supplement 14 · standard — Label ↗AP
2000-11-06Manufacturing (CMC) · Supplement 15 · standardAP
2000-08-08Manufacturing (CMC) · Supplement 13 · standardAP
1999-03-12Manufacturing (CMC) · Supplement 12 · standardAP
1998-02-20Manufacturing (CMC) · Supplement 10 · standardAP
1997-02-21Manufacturing (CMC) · Supplement 9 · standardAP
1996-04-04Manufacturing (CMC) · Supplement 8 · standardAP
1996-01-26Manufacturing (CMC) · Supplement 7 · standardAP
1991-03-19Labeling · Supplement 6AP
1988-02-25Labeling · Supplement 5AP
1986-08-08Manufacturing (CMC) · Supplement 4 · standardAP
1986-06-11Labeling · Supplement 3AP
1981-05-22Manufacturing (CMC) · Supplement 1 · standardAP
1979-11-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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