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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022328
Company: PURDUE PHARMA

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 022328

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INTERMEZZO	ZOLPIDEM TARTRATE	1.75MG	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
INTERMEZZO	ZOLPIDEM TARTRATE	3.5MG	TABLET;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022328

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2011	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/2011/022328lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022328s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022328Orig1s008ltr.pdf
02/06/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022328Orig1s007ltr.pdf
09/11/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022328Orig1s004ltr.pdf
11/13/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/14/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/06/2013	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf

Labels for NDA 022328

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf
02/06/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s007lbl.pdf
09/11/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf
02/06/2013	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf
11/23/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022328lbl.pdf

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