FDA NDA · NDA021351

OXYTROL

oxybutynin

Sponsor: ALLERGAN

APPLICATION

NDA021351

TYPE

NDA

ORIGINAL APPROVAL

2003-02-26

LATEST ACTION

2024-05-29

ROUTE

TRANSDERMAL

DOSAGE FORM

FILM, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

OXYTROL · ReferencePrescription

OXYBUTYNIN 3.9MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

2024-05-29Labeling · Supplement 20 · standard — Letter ↗AP

2017-10-24Labeling · Supplement 18 · standard — Label ↗AP

2017-10-24Labeling · Supplement 17 · standard — Label ↗AP

2015-07-10Labeling · Supplement 16 · standard — Letter ↗AP

2014-07-18Manufacturing (CMC) · Supplement 15 · standardAP

2014-05-16Manufacturing (CMC) · Supplement 14 · standardAP

2013-07-10Manufacturing (CMC) · Supplement 12 · standardAP

2013-07-03Manufacturing (CMC) · Supplement 7 · standardAP

2013-05-29Manufacturing (CMC) · Supplement 10 · standardAP

2013-03-15Manufacturing (CMC) · Supplement 11 · standardAP

2012-10-10Labeling · Supplement 9 · standard — Label ↗AP

2012-10-10Labeling · Supplement 8 · standard — Letter ↗AP

2011-01-31Labeling · Supplement 5 · standard — Letter ↗AP

2006-07-05Labeling · Supplement 2 · standard — Letter ↗AP

2003-02-26Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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