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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207356
Company: INSMED INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIKAYCE KIT AMIKACIN SULFATE EQ 590MG BASE/8.4ML SUSPENSION, LIPOSOMAL;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
09/28/2018 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207356Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207356Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/13/2020 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s004ltr.pdf
10/19/2020 SUPPL-3 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/13/2020 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf
03/13/2020 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf
09/28/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdf
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