BUTRANS از شرکت PURDUE PHARMA LP

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

BUTRANS از شرکت PURDUE PHARMA LP

New Drug Application (NDA): 021306

Company: PURDUE PHARMA LP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTRANS BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

Yes No
BUTRANS BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

Yes No
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

Yes Yes
BUTRANS BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription

AB

Yes No
BUTRANS BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
06/30/2010 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021306s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306_butrans_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021306Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-37 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021306s037lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021306Orig1s037ltr.pdf

10/07/2019 SUPPL-35 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021306s035lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021306Orig1s035ltr.pdf

09/18/2018 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf

09/18/2018 SUPPL-32 REMS – MODIFIED – D-N-A

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021306Orig1s032s036ltr.pdf

08/14/2017 SUPPL-31 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s031ltr.pdf

05/26/2017 SUPPL-30 REMS-Modified

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306Orig1s030ltr.pdf

10/13/2017 SUPPL-27 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021306Orig1s027ltr.pdf

09/30/2016 SUPPL-26 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s026ltr.pdf

12/16/2016 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s024ltr.pdf

04/20/2016 SUPPL-23 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021306Orig1s023ltr.pdf

06/26/2015 SUPPL-22 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021306Orig1s022ltr.pdf

08/19/2014 SUPPL-20 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s020ltr.pdf

06/30/2014 SUPPL-19 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf

04/16/2014 SUPPL-18 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s018ltr.pdf

07/25/2013 SUPPL-16 Manufacturing (CMC)

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s016ltr.pdf

06/30/2014 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021306Orig1s015,s019ltr.pdf

03/08/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-12 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021306Orig1s012ltr.pdf

07/09/2012 SUPPL-8 Labeling, REMS-Modified

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021306Orig1s008ltr.pdf

07/01/2011 SUPPL-3 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf

07/01/2011 SUPPL-1 Labeling-Patient Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021306s001,s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2021 SUPPL-37

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021306s037lbl.pdf
10/07/2019 SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021306s035lbl.pdf
09/18/2018 SUPPL-34

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
09/18/2018 SUPPL-34

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
09/18/2018 SUPPL-32

REMS – MODIFIED – D-N-A

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf
10/13/2017 SUPPL-27

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf
05/26/2017 SUPPL-30

REMS-Modified

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306Orig1s030ltr.pdf
12/16/2016 SUPPL-24

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf
12/16/2016 SUPPL-24

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021306s024lbl.pdf
06/30/2014 SUPPL-19

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
06/30/2014 SUPPL-15

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
06/30/2014 SUPPL-15

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf
04/16/2014 SUPPL-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf
07/25/2013 SUPPL-16

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf
07/09/2012 SUPPL-8

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf
07/09/2012 SUPPL-8

REMS-Modified

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021306s008lbl.pdf
07/01/2011 SUPPL-3

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf
07/01/2011 SUPPL-1

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf
06/30/2010 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf

BUTRANS

FILM, EXTENDED RELEASE;TRANSDERMAL; 5MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 10MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 10MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 20MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 20MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 15MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 15MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP

FILM, EXTENDED RELEASE;TRANSDERMAL; 7.5MCG/HR

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 211586 AMNEAL
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 210162 MYLAN TECHNOLOGIES
BUPRENORPHINE BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 204937 WATSON LABS TEVA
BUTRANS BUPRENORPHINE 7.5MCG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 021306 PURDUE PHARMA LP
حتما بخوانید : ALEVE PM از شرکت BAYER HLTHCARE
بخوانید  CHLORPROMAZINE HYDROCHLORIDE از شرکت WYETH AYERST
به بالای صفحه بردن