Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018401
Company: INDIVIOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPRENEX BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
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
10/07/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018401s025lbl.pdf

BUPRENEX

INJECTABLE;INJECTION; EQ 0.3MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENEX BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 018401 INDIVIOR INC
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 078331 AM REGENT
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076931 HIKMA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074137 HOSPIRA
BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206586 PAR STERILE PRODUCTS

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