Drugs@FDA: FDA Approved Drug Products

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

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 202657 MYLAN
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 202657 MYLAN
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;SUBLINGUAL Prescription No AB 201509 PAR FORM

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