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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209080
Company: ITALFARMACO SA

Products on NDA 209080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIGLUTIK KIT	RILUZOLE	50MG/10ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209080s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209080Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209080Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209080s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209080Orig1s003ltr.pdf
12/13/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209080s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209080Orig1s001ltr.pdf

Labels for NDA 209080

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/11/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209080s003lbl.pdf
12/13/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209080s001lbl.pdf
09/05/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209080s000lbl.pdf

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