Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021879
Company: AVANIR PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUEDEXTA DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20MG;10MG CAPSULE;ORAL Prescription None 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
10/29/2010 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021879Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2017 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

11/18/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/14/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021879Orig1s005ltr.pdf
11/30/2012 SUPPL-2 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
01/20/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021879s005lbl.pdf
10/29/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021879s000lbl.pdf

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