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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021997
Company: MYLAN SPECIALITY LP

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.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021997s000TOC.cfm

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-Container/Carton Labels, Labeling-Medication Guide	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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf
10/29/2014	SUPPL-6	Labeling-Medication Guide	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	MYLAN SPECIALITY LP
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	PAR FORM

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	MYLAN SPECIALITY LP
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	PAR FORM

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