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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022124
Company: NYCOMED US INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNARIS CICLESONIDE 50MCG SPRAY; NASAL 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
11/21/2007 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022124s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022124_omnaris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022124s000_SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022124lbl.pdf
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