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New Drug Application (NDA): 021774
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMBIEN CR ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
AMBIEN CR ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes 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
09/02/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021774ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021774s000_AmbienTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2022 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf
08/18/2019 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s046, 021774Orig1s027ltr.pdf
02/06/2019 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s045, 021774Orig1s026ltr.pdf
02/23/2022 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf
09/14/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf
02/23/2022 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf
03/03/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf
12/02/2016 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf
08/11/2016 SUPPL-17 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-16 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-15 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
04/19/2013 SUPPL-13 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-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021774s010ltr.pdf
12/20/2007 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf
12/20/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf
12/20/2007 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf
12/20/2007 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf
12/20/2007 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021774Orig1s003.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2022 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf
02/23/2022 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf
02/23/2022 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf
08/18/2019 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf
02/06/2019 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s026lbl.pdf
09/14/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf
03/03/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf
12/02/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf
08/11/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf
10/07/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf
04/19/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/19/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/14/2010 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf
12/20/2007 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
09/02/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf

AMBIEN CR

TABLET, EXTENDED RELEASE;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN CR ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021774 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213592 BRECKENRIDGE
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078970 LUPIN LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090107 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204170 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 6.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN CR ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021774 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213592 BRECKENRIDGE
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078970 LUPIN LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090107 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204170 SUN PHARM
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