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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021351
Company: ALLERGAN

Products on NDA 021351

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYTROL	OXYBUTYNIN	3.9MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021351

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021351lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021351Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-351_Oxytrol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2024	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021351Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021351Orig1s020ltr.pdf
10/24/2017	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021351Orig1s017,021351Orig1s018ltr.pdf
10/24/2017	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021351Orig1s017,021351Orig1s018ltr.pdf
07/10/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021351s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021351Orig1s016ltr.pdf
07/18/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/16/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/10/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/15/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/29/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/10/2012	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf
10/10/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf
07/03/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/31/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021351s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021351s005ltr.pdf
07/05/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021351s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021351s002LTR.pdf

Labels for NDA 021351

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2024	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021351Orig1s020lbl.pdf
10/24/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf
10/24/2017	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021351s017s018lbl.pdf
07/10/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021351s016lbl.pdf
10/10/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf
10/10/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf
01/31/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021351s005lbl.pdf
07/05/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021351s002lbl.pdf
02/26/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021351lbl.pdf

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