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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207356
Company: INSMED INC

Medication Guide

Products on NDA 207356

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207356

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
06/01/2023	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s013ltr.pdf
02/10/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s012ltr.pdf
03/13/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	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	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s003ltr.pdf

Labels for NDA 207356

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf
02/10/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf
10/19/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356Orig1s003Lbl.pdf
03/13/2020	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf
03/13/2020	SUPPL-4	Labeling-Package Insert	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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