Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204242
Company: OREXO US INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 1.4MG BASE;EQ 0.36MG BASE TABLET;SUBLINGUAL Prescription None Yes No
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 5.7MG BASE;EQ 1.4MG BASE TABLET;SUBLINGUAL Prescription None Yes No
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 8.6MG BASE;EQ 2.1MG BASE TABLET;SUBLINGUAL Prescription None Yes No
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 11.4MG BASE;EQ 2.9MG BASE TABLET;SUBLINGUAL Prescription None Yes Yes
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2.9MG BASE;EQ 0.71MG BASE TABLET;SUBLINGUAL Prescription None Yes No
ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 0.7MG BASE;EQ 0.18MG BASE TABLET;SUBLINGUAL Prescription 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
07/03/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2018 SUPPL-15 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s015ltr.pdf
02/01/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s014ltr.pdf
05/23/2017 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s012ltr.pdf
09/08/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s011ltr.pdf
12/16/2016 SUPPL-9 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s009ltr.pdf
07/07/2016 SUPPL-8 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf
10/04/2016 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s007ltr.pdf
06/04/2015 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf
02/12/2015 SUPPL-5 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf
08/10/2015 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf
12/11/2014 SUPPL-3 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf
09/04/2013 SUPPL-2 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf
01/14/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf
09/08/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf
12/16/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf
12/16/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf
10/04/2016 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf
08/10/2015 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf
06/04/2015 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf
12/11/2014 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf
07/03/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf

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