Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022383
Company: SUNOVION PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARCAPTA NEOHALER INDACATEROL MALEATE EQ 75MCG BASE POWDER;INHALATION 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
07/01/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022383s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2012 SUPPL-5 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf
12/18/2012 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf
02/25/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/26/2012 SUPPL-2 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/26/2012 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf
07/01/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf

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