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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219622
Company: CHIESI FARMACEUTICI SPA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIMBOW BECLOMETHASONE DIPROPIONATE, FORMOTEROL FUMARATE, AND GLYCOPYRROLATE 86MCG/4.9MCG/10.6MCG, 86MCG, 4.9MCG, 10.6MCG AEROSOL;INHALATION Prescription None No No
TRIMBOW BECLOMETHASONE DIPROPIONATE, FORMOTEROL FUMARATE, AND GLYCOPYRROLATE 172MCG/4.9MCG/10.6MCG, 172MCG, 4.9MCG, 10.6MCG AEROSOL;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
05/14/2026 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219622Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219622Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/14/2026 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219622Orig1s001lbl.pdf
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