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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022196
Company: AYTU

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022196

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIMIST	ZOLPIDEM TARTRATE	5MG/SPRAY	SPRAY, METERED;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022196

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022196S000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022196s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022196Orig1s012ltr.pdf
02/06/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022196Orig1s011ltr.pdf
09/28/2011	SUPPL-7	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022196s007ltr.pdf
10/11/2010	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022196s003ltr.pdf

Labels for NDA 022196

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s012lbl.pdf
02/06/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s011lbl.pdf
12/19/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022196lbl.pdf

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