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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202211
Company: ABBVIE

Summary Review

Products on NDA 202211

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/2013	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211_oxytrol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2016	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf
05/15/2014	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
08/16/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/20/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202211

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2016	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf
01/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

OXYTROL FOR WOMEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FILM, EXTENDED RELEASE;TRANSDERMAL; 3.9MG/24HR

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OXYTROL FOR WOMEN	OXYBUTYNIN	3.9MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Over-the-counter	Yes	202211	ABBVIE

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