Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020732
Company: INDIVIOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUBUTEX BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None Yes No
SUBUTEX BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None Yes No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
10/08/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20732,20733ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-732_20-733_Subutex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020732Orig1s024ltr.pdf
03/02/2020 SUPPL-23 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020732Orig1s023, 020733Orig1s027, 022410Orig1s039ltr.pdf
10/07/2019 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020732Orig1s022ltr.pdf
10/26/2018 SUPPL-21 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022410Orig1s035,020733Orig1s025,020732Orig1s021Ltr.pdf
10/31/2019 SUPPL-20 REMS-Modified, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s034, 020732Orig1s020, 020733Orig1s024ltr.pdf
06/11/2018 SUPPL-19 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s019,020733Orig1s023,022410Orig1s033ltr.pdf
02/01/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020732Orig1s018ltr.pdf
09/19/2017 SUPPL-17 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf
09/07/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020732s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s016ltr.pdf
12/16/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf
12/16/2016 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s014,s015ltr.pdf
07/07/2016 SUPPL-13 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf
09/22/2015 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020732Orig1s012,020733Orig1s016ltr.pdf
12/11/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020732Orig1s010ltr.pdf
08/08/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/22/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf
12/22/2011 SUPPL-6 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf
10/04/2006 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020732s002,020733s003LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2021 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf
10/31/2019 SUPPL-20 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf
10/31/2019 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s020lbl.pdf
10/07/2019 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf
10/07/2019 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020732s022lbl.pdf
06/11/2018 SUPPL-19 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf
02/01/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf
09/07/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020732s016lbl.pdf
12/16/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf
12/16/2016 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020732s014s015lbl.pdf
12/11/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020732Orig1s010lbl.pdf
12/22/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf
12/22/2011 SUPPL-6 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf
10/08/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf

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