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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022335
Company: CYCLOMEDICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNEGAS KIT TECHNETIUM TC-99M LABELED CARBON N/A AEROSOL;INHALATION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022335Orig1s000lbl.pdf
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