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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215007
Company: NEXAIR LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBON DIOXIDE, USP CARBON DIOIDE 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
07/18/2020 ORIG-1 Approval UNKNOWN Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/215007Orig1s000MGltr.pdf
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