Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211739
Company: CRISTAL ASU LLC

Products on NDA 211739

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211739

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2018	ORIG-1	Approval		UNKNOWN	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/NDA211739-NADA141497-DeemedGranted.pdf