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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018211
Company: ORTHO MCNEIL JANSSEN

Products on NDA 018211

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DITROPAN	OXYBUTYNIN CHLORIDE	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/1979	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2008	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018211s017ltr.pdf
04/15/2003	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf
11/06/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/2003	SUPPL-14	Labeling	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018211_s014&s016_DITROPAN TABLETS.pdf
08/08/2000	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/12/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/20/1998	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
02/21/1997	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/04/1996	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
01/26/1996	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/19/1991	SUPPL-6	Labeling		Label is not available on this site.
02/25/1988	SUPPL-5	Labeling		Label is not available on this site.
08/08/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/11/1986	SUPPL-3	Labeling		Label is not available on this site.
03/13/2009	SUPPL-2	Labeling		Label is not available on this site.
05/22/1981	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018211

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2008	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf
04/15/2003	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf
04/15/2003	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf

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