Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077322
Company: SANDOZ INC
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 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077322s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077322s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2015 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/04/2013 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/30/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/10/2009 SUPPL-6 Labeling

Label is not available on this site.

05/13/2008 SUPPL-5 Labeling

Label is not available on this site.

05/23/2008 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/23/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077322s000lbl.pdf

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 CIPLA LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078184 INVAGEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 076578 MYLAN
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077322 SANDOZ INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077359 SUN PHARM INDS INC
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
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078616 VINTAGE
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078426 WOCKHARDT
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077990 YUNG SHIN PHARM

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 CIPLA LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078184 INVAGEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 076578 MYLAN
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077322 SANDOZ INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077359 SUN PHARM INDS INC
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
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078616 VINTAGE
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078426 WOCKHARDT
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077990 YUNG SHIN PHARM

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