AMBIEN CR 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
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AMBIEN CR از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 021774

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
AMBIEN CRZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

YesYes
AMBIEN CRZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescription

AB

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
09/02/2005ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
08/18/2019SUPPL-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

02/06/2019SUPPL-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

09/14/2018SUPPL-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

03/03/2017SUPPL-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

12/02/2016SUPPL-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

08/11/2016SUPPL-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

10/07/2014SUPPL-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

04/19/2013SUPPL-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

04/19/2013SUPPL-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

04/14/2010SUPPL-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

12/20/2007SUPPL-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

12/20/2007SUPPL-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

12/20/2007SUPPL-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

12/20/2007SUPPL-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

12/20/2007SUPPL-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
08/18/2019SUPPL-27

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf
02/06/2019SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s026lbl.pdf
09/14/2018SUPPL-23

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf
03/03/2017SUPPL-19

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf
12/02/2016SUPPL-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf
08/11/2016SUPPL-17

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf
10/07/2014SUPPL-16

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf
04/19/2013SUPPL-15

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/19/2013SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf
04/14/2010SUPPL-10

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf
12/20/2007SUPPL-8

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007SUPPL-7

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007SUPPL-5

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007SUPPL-4

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
12/20/2007SUPPL-3

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf
09/02/2005ORIG-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMBIEN CRZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB021774SANOFI AVENTIS US
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078179ACTAVIS ELIZABETH
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB090153ACTAVIS LABS FL INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078148ANCHEN PHARMS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB200266APOTEX INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB213592BRECKENRIDGE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078970LUPIN LTD
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB090107SANDOZ
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB204170SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 6.25MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
AMBIEN CRZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionYesAB021774SANOFI AVENTIS US
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078179ACTAVIS ELIZABETH
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB090153ACTAVIS LABS FL INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078148ANCHEN PHARMS
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB200266APOTEX INC
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB213592BRECKENRIDGE
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB078970LUPIN LTD
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB090107SANDOZ
ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE;ORALPrescriptionNoAB204170SUN PHARM
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