Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019908
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMBIEN ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription AB Yes No
AMBIEN ZOLPIDEM TARTRATE 10MG TABLET;ORAL 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
12/16/1992 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S000_AmbienTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf
12/02/2016 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf
08/11/2016 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf
10/07/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf
04/19/2013 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf
06/05/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf
04/14/2010 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019908s029ltr.pdf
05/07/2008 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019908s024, s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019908Orig1s027.pdf
10/04/2007 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s025_LTR_rev2_cd_revised.pdf
03/28/2007 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s022ltr.pdf
10/04/2007 SUPPL-20 Labeling

Label is not available on this site.

09/25/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/21/2002 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/15/2002 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/15/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/04/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/13/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-9 Labeling

Label is not available on this site.

04/18/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/04/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1995 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/14/1995 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S002_AMBIEN_AP.pdf
07/14/1995 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/03/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf
12/02/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf
08/11/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf
10/07/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf
04/19/2013 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/19/2013 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/14/2010 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf
05/07/2008 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf
03/28/2007 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf

AMBIEN

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 ALLIED PHARMA INC
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 078055 SUN PHARM INDS LTD
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 ALLIED PHARMA INC
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 078055 SUN PHARM INDS LTD
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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