Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205911
Company: PRAXAIR DISTRIBUTION MID-ATLANTIC LLC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/05/2013 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205911Orig1s000ltr.pdf

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