AMBIEN از شرکت SANOFI AVENTIS US

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AMBIEN از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 019908

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMBIENZOLPIDEM TARTRATE5MGTABLET;ORALPrescription

AB

YesNo
AMBIENZOLPIDEM TARTRATE10MGTABLET;ORALPrescription

AB

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
12/16/1992ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
08/18/2019SUPPL-46 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s046, 021774Orig1s027ltr.pdf

02/06/2019SUPPL-45 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s045lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s045, 021774Orig1s026ltr.pdf

09/14/2018SUPPL-42 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf

03/03/2017SUPPL-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

12/02/2016SUPPL-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

08/11/2016SUPPL-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

10/07/2014SUPPL-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

04/19/2013SUPPL-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

06/05/2013SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/19/2013SUPPL-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

04/14/2010SUPPL-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

05/07/2008SUPPL-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

10/04/2007SUPPL-25 Labeling

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019908Orig1s025.pdf

10/04/2007SUPPL-24

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf

03/28/2007SUPPL-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

10/04/2007SUPPL-20 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

12/01/1999SUPPL-9 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

07/14/1995SUPPL-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

07/14/1995SUPPL-1 Labeling

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
08/18/2019SUPPL-46

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf
02/06/2019SUPPL-45

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s045lbl.pdf
09/14/2018SUPPL-42

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf
03/03/2017SUPPL-38

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf
12/02/2016SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf
08/11/2016SUPPL-36

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf
10/07/2014SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf
04/19/2013SUPPL-34

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/19/2013SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/14/2010SUPPL-29

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf
05/07/2008SUPPL-27

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf
03/28/2007SUPPL-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMBIENZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionYesAB019908SANOFI AVENTIS US
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB077214ACME LABS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB077884APOTEX INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB078413AUROBINDO PHARMA
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB077388CIPLA LTD
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB078184INVAGEN PHARMS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB077322SANDOZ INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB076410TEVA
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET;ORALPrescriptionNoAB077903TORRENT PHARMS

TABLET;ORAL; 10MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMBIENZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionYesAB019908SANOFI AVENTIS US
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB077214ACME LABS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB077884APOTEX INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB078413AUROBINDO PHARMA
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB077388CIPLA LTD
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB078184INVAGEN PHARMS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB077322SANDOZ INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB076410TEVA
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET;ORALPrescriptionNoAB077903TORRENT PHARMS
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