An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021997
Company: VIATRIS

Medication Guide

Summary Review

Products on NDA 021997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EDLUAR	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	AB	Yes	No
EDLUAR	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021997lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021997s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-11	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021997Orig1s011ltr.pdf
02/06/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021997Orig1s010ltr.pdf
10/24/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021997s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021997Orig1s008ltr.pdf
10/29/2014	SUPPL-6	Labeling-Medication Guide, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021997Orig1s006ltr.pdf
04/19/2013	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021997s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021997Orig1s005ltr.pdf
08/10/2011	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021997s003ltr.pdf
12/17/2010	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021997s002ltr.pdf

Labels for NDA 021997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2019	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf
02/06/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s010lbl.pdf
10/24/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021997s008lbl.pdf
10/29/2014	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf
10/29/2014	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf
04/19/2013	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021997s005lbl.pdf
03/13/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021997lbl.pdf

Therapeutic Equivalents for NDA 021997

EDLUAR

TABLET;SUBLINGUAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDLUAR	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	Yes	AB	021997	VIATRIS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	PH HEALTH

TABLET;SUBLINGUAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDLUAR	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	Yes	AB	021997	VIATRIS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	PH HEALTH

Top