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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201509
Company: ENDO OPERATIONS
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
08/01/2016 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

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 201509 ENDO OPERATIONS

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 ENDO OPERATIONS
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