Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021351
Company: ALLERGAN
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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