Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022410
Company: INDIVIOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB Yes No
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB Yes No
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4MG BASE;EQ 1MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB Yes No
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription AB 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
08/30/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022410Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/02/2020 SUPPL-39 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-38 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s038ltr.pdf
10/26/2018 SUPPL-35 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-34 Labeling-Medication Guide, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022410Orig1s034, 020732Orig1s020, 020733Orig1s024ltr.pdf
06/11/2018 SUPPL-33 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-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022410Orig1s031ltr.pdf
09/19/2017 SUPPL-30 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020732Orig1s017,020733Orig1s021,022410Orig1s030ltr.pdf
09/19/2017 SUPPL-29 REMS-Assessment

Label is not available on this site.

01/12/2017 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf
12/16/2016 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022410Orig1s026,s027ltr.pdf
07/07/2016 SUPPL-25 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020732Orig1s013,020733Orig1s017,022410Orig1s025ltr.pdf
04/15/2016 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/13/2017 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022410Orig1s023ltr.pdf
09/22/2015 SUPPL-22 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf
06/23/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/22/2015 SUPPL-20 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022410Orig1s020,s022ltr.pdf
08/12/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/28/2014 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf
04/28/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf
06/05/2014 SUPPL-16 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s016.pdf
11/22/2013 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022410Orig1s015ltr.pdf
03/12/2014 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022410Orig1s014.pdf
08/08/2013 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022410Orig1s011.pdf
08/10/2012 SUPPL-7 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s007.pdf
08/10/2012 SUPPL-6 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022410Orig1s006.pdf
04/28/2014 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022410Orig1s004,s017,s018ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/31/2019 SUPPL-34 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf
10/31/2019 SUPPL-34 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024,022410s034lbl.pdf
10/07/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf
10/07/2019 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf
06/11/2018 SUPPL-33 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf
02/01/2018 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s031lbl.pdf
02/13/2017 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022410s023lbl.pdf
12/16/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf
12/16/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf
12/16/2016 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022410s026s027lbl.pdf
09/22/2015 SUPPL-22 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf
09/22/2015 SUPPL-20 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022410s020s022lbl.pdf
04/28/2014 SUPPL-18 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf
04/28/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf
04/28/2014 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022410s004s017s018lbl.pdf
11/22/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022410s015lbl.pdf
08/10/2012 SUPPL-7 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf
08/10/2012 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022410s006s007lbl.pdf
08/30/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022410s000lbl.pdf

SUBOXONE

FILM;BUCCAL, SUBLINGUAL; EQ 2MG BASE;EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205299 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 211785 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2MG BASE;EQ 0.5MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

FILM;BUCCAL, SUBLINGUAL; EQ 8MG BASE;EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205299 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 207607 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8MG BASE;EQ 2MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

FILM;BUCCAL, SUBLINGUAL; EQ 4MG BASE;EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4MG BASE;EQ 1MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4MG BASE;EQ 1MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205806 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4MG BASE;EQ 1MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 211785 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4MG BASE;EQ 1MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

FILM;BUCCAL, SUBLINGUAL; EQ 12MG BASE;EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205954 ALVOGEN PINE BROOK
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 205806 DR REDDYS LABS SA
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription No AB 207607 MYLAN TECHNOLOGIES
SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 12MG BASE;EQ 3MG BASE FILM;BUCCAL, SUBLINGUAL Prescription Yes AB 022410 INDIVIOR INC

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