← FDA DRUG APPROVALS

FDA NDA · NDA020897

DITROPAN XL

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020897
TYPE
NDA
ORIGINAL APPROVAL
1998-12-16
LATEST ACTION
2021-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DITROPAN XL · ReferenceDiscontinued
OXYBUTYNIN CHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
DITROPAN XL · ReferenceDiscontinued
OXYBUTYNIN CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
DITROPAN XL · ReferenceDiscontinued
OXYBUTYNIN CHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-03-29Labeling · Supplement 38 · standard — Label ↗AP
2019-09-12Labeling · Supplement 37 · standard — Letter ↗AP
2018-10-26Labeling · Supplement 36 · standard — Letter ↗AP
2016-09-13Labeling · Supplement 35 · standard — Letter ↗AP
2015-02-27Labeling · Supplement 33 · standard — Label ↗AP
2013-08-01Labeling · Supplement 32 · standard — Label ↗AP
2012-11-13Labeling · Supplement 31 · standard — Label ↗AP
2012-03-23Labeling · Supplement 30 · standard — Label ↗AP
2011-12-15Labeling · Supplement 29 · unknown — Letter ↗AP
2011-06-28Labeling · Supplement 28 · unknown — Letter ↗AP
2009-07-13Labeling · Supplement 24 · standard — Label ↗AP
2008-02-06Labeling · Supplement 18 · standard — Letter ↗AP
2004-06-30Efficacy · Supplement 13 · standard — Letter ↗AP
2003-04-15Efficacy · Supplement 9 · standard — Label ↗AP
2003-04-15Labeling · Supplement 10 · standard — Letter ↗AP
2000-04-17Labeling · Supplement 8 · standardAP
1999-09-29Manufacturing (CMC) · Supplement 7 · standardAP
1999-09-28Manufacturing (CMC) · Supplement 5 · standardAP
1999-07-20Manufacturing (CMC) · Supplement 6 · standardAP
1999-06-30Manufacturing (CMC) · Supplement 4 · standardAP
1999-06-22Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1999-06-09Manufacturing (CMC) · Supplement 1 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 3 · standardAP
1998-12-16Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗AP
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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