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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018401
Company: INDIVIOR

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENEX BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/29/1981 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018401s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018401Orig1s027ltr.pdf
06/17/2022 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018401s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018401Orig1s026ltr.pdf
10/07/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018401Orig1s025ltr.pdf
12/16/2016 SUPPL-22 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018401Orig1s022ltr.pdf
05/11/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
08/08/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
02/06/2014 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
01/04/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
06/10/2003 SUPPL-15 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18401slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018401_S015_Buprenex Injectable_APPROVAL PACKAGE.pdf
02/11/2002 SUPPL-14 Labeling Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18401s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018401_s014_BuprenexTOC.cfm
11/29/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
02/13/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
06/25/1993 SUPPL-11 Labeling

Label is not available on this site.
04/29/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
12/05/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/09/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
11/19/1987 SUPPL-5 Labeling

Label is not available on this site.
02/13/1987 SUPPL-4 Labeling

Label is not available on this site.
05/17/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
10/19/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
06/28/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018401s027lbl.pdf
06/17/2022 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018401s026lbl.pdf
10/07/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf
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