Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213170
Company: LA JOLLA PHARMA

Products on NDA 213170

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARTESUNATE	ARTESUNATE	UNKNOWN	INJECTABLE;INJECTION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213170

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2020	ORIG-1	Tentative Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213170Orig1s000TAltr.pdf