Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205637
Company: BDSI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2.1MG BASE;EQ 0.3MG BASE FILM;BUCCAL Discontinued None Yes No
BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4.2MG BASE;EQ 0.7MG BASE FILM;BUCCAL Discontinued None Yes No
BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 6.3MG BASE;EQ 1MG BASE FILM;BUCCAL Discontinued None 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
06/06/2014 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/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 Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-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
10/07/2019 SUPPL-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
10/31/2018 SUPPL-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
02/01/2018 SUPPL-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
05/23/2017 SUPPL-14 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205637Orig1s014ltr.pdf
04/27/2017 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide 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
12/16/2016 SUPPL-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
07/07/2016 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf
04/27/2017 SUPPL-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
10/14/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/12/2015 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf
04/24/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2021 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
10/07/2019 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf
02/01/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf
04/27/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
04/27/2017 SUPPL-7 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205637s007s013lbl.pdf
12/16/2016 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
12/16/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205637s011lbl.pdf
06/06/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf

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