Ditropan

NDA 18211, held by Ortho Mcneil Janssen. Oxybutynin Chloride.

As of Nov 13, 2026, NDA 18211 (Ditropan), held by Ortho Mcneil Janssen, was first approved by FDA on Nov 29, 1979, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 29, 1979
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Apr 15, 2003	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 29, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ditropan5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Oxybutynin Chloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 2Labeling	Approved	None posted
Feb 6, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 15, 2003	Supplement 14Labeling · Standard review	Approved	Review Label
Apr 15, 2003	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 6, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 8, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 12, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 20, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 21, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 4, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 26, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 19, 1991	Supplement 6Labeling	Approved	None posted
Feb 25, 1988	Supplement 5Labeling	Approved	None posted
Aug 8, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 11, 1986	Supplement 3Labeling	Approved	None posted
May 22, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 29, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18211
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil-Janssen Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters