Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202657
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;SUBLINGUAL Prescription AB No No
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;SUBLINGUAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/08/2016 ORIG-1 Approval

Label is not available on this site.

ZOLPIDEM TARTRATE

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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