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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076410
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription AB No No
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL 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
04/23/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076410s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2023 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/08/2023 SUPPL-28 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/15/2019 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/15/2019 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
11/15/2019 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
11/15/2019 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
11/15/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
03/19/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
09/04/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
12/08/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
11/06/2008 SUPPL-4 Labeling

Label is not available on this site.

ZOLPIDEM TARTRATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription Yes AB 019908 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077214 ACME LABS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077884 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078413 AUROBINDO PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077388 CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077322 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 076410 TEVA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077903 TORRENT PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription Yes AB 019908 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077214 ACME LABS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077884 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078413 AUROBINDO PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077388 CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077322 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 076410 TEVA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077903 TORRENT PHARMS
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