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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217500
Company: ABSOLUTE AIR, LLC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/10/2022 ORIG-1 Approval UNKNOWN Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/217500Orig1s000MGLtr.pdf
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