BUNAVAIL از شرکت BDSI

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

BUNAVAIL از شرکت BDSI

New Drug Application (NDA): 205637

Company: BDSI

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
BUNAVAILBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2.1MG BASE;EQ 0.3MG BASEFILM;BUCCALDiscontinued

None

YesNo
BUNAVAILBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 4.2MG BASE;EQ 0.7MG BASEFILM;BUCCALDiscontinued

None

YesNo
BUNAVAILBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 6.3MG BASE;EQ 1MG BASEFILM;BUCCALDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
06/06/2014ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205637Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000SumR.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
03/04/2021SUPPL-21 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205637Orig1s021ltr.pdf

10/07/2019SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205637Orig1s020ltr.pdf

10/31/2018SUPPL-19 REMS – PROPOSAL – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s019ltr.pdf

02/01/2018SUPPL-16 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205637Orig1s016ltr.pdf

05/23/2017SUPPL-14 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s014ltr.pdf

04/27/2017SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf

12/16/2016SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s011ltr.pdf

07/07/2016SUPPL-9 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf

04/27/2017SUPPL-7 Labeling-Package Insert, Efficacy-New Dosing Regimen

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s007,205637Orig1s013ltr.pdf

10/14/2015SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/12/2015SUPPL-4 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf

04/24/2015SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/25/2018SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
03/04/2021SUPPL-21

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf
10/07/2019SUPPL-20

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
10/07/2019SUPPL-20

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
02/01/2018SUPPL-16

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf
04/27/2017SUPPL-13

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017SUPPL-7

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017SUPPL-7

Efficacy-New Dosing Regimen

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
12/16/2016SUPPL-11

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
12/16/2016SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
06/06/2014ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf
بخوانید  CLOBAZAM از شرکت TEVA PHARMS USA
اسکرول به بالا