Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205718
Company: HELSINN HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKYNZEO NETUPITANT; PALONOSETRON HYDROCHLORIDE 300MG;EQ 0.5MG BASE 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
10/10/2014 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/28/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/12/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/20/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/27/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf
04/29/2015 SUPPL-2 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
02/16/2015 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
04/29/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
04/27/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s003lbl.pdf
10/10/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf

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