Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 213990
Company: ILMO Products Company

Products on NDA 213990

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HELIUM, USP	HELIUM	N/A	GAS;INHALATION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2019	ORIG-1	Approval		UNKNOWN	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213990orig1s000MGltr.pdf