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Submitted URL: https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxNDYsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkI...
Effective URL: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=204242&event=overview.process&utm_medium=&utm_source=
Submission: On December 21 via manual from US — Scanned from DE

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New Drug Application (NDA): 204242
Company: OREXO US INC
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 * Medication Guide

 * REMS



PRODUCTS ON NDA 204242

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
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

Showing 1 to 6 of 6 entries

APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR NDA 204242

ORIGINAL APPROVALS OR TENTATIVE APPROVALS

CSVExcelPrint

Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan
Status Letters, Reviews, Labels, Patient Package InsertNotes 07/03/2013 ORIG-1
Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review


Showing 1 to 1 of 1 entries

SUPPLEMENTS

CSVExcelPrint

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews,
Labels, Patient Package Insert Note 12/16/2022 SUPPL-24 REMS - MODIFIED - D-N-A

Label is not available on this site.

06/17/2022 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
06/17/2022 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
05/03/2022 SUPPL-22 REMS - MODIFIED - D-N-A Letter (PDF)


Label is not available on this site.

03/04/2021 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
10/07/2019 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide Label
(PDF)
Letter (PDF)
10/31/2018 SUPPL-15 REMS - MODIFIED - D-N-A Letter (PDF)


Label is not available on this site.

02/01/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
09/08/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
05/23/2017 SUPPL-12 REMS-Modified Letter (PDF)


Label is not available on this site.

12/16/2016 SUPPL-9 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
10/04/2016 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
07/07/2016 SUPPL-8 REMS-Modified Letter (PDF)


Label is not available on this site.

08/10/2015 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
06/04/2015 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
02/12/2015 SUPPL-5 REMS-Modified Letter (PDF)


Label is not available on this site.

12/11/2014 SUPPL-3 Manufacturing (CMC) Label (PDF)
Letter (PDF)
01/14/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

09/04/2013 SUPPL-2 REMS-Proposal Letter (PDF)


Label is not available on this site.

Showing 1 to 19 of 19 entries

LABELS FOR NDA 204242

CSVExcelPrint

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews,
Labels,
Patient Package InsertNote 06/17/2022 SUPPL-23 Labeling-Package Insert Label
(PDF) 06/17/2022 SUPPL-21 Labeling-Package Insert Label (PDF) 03/04/2021
SUPPL-19 Labeling-Package Insert Label (PDF) 10/07/2019 SUPPL-17
Labeling-Package Insert Label (PDF) 10/07/2019 SUPPL-17 Labeling-Medication
Guide Label (PDF) 02/01/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
09/08/2017 SUPPL-11 Labeling-Package Insert Label (PDF) 12/16/2016 SUPPL-9
Labeling-Package Insert Label (PDF) 12/16/2016 SUPPL-9 Labeling-Package Insert
Label (PDF) 10/04/2016 SUPPL-7 Efficacy-Manufacturing Change With Clinical Data
Label (PDF) 08/10/2015 SUPPL-4 Efficacy-New Indication Label (PDF) 06/04/2015
SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually
require new labeling. 12/11/2014 SUPPL-3 Manufacturing (CMC) Label (PDF) This
supplement type does not usually require new labeling. 07/03/2013 ORIG-1
Approval Label (PDF)

Showing 1 to 14 of 14 entries



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