Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022220
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIVARIS TRIAMCINOLONE ACETONIDE 8MG/0.1ML (8MG/0.1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL Discontinued None Yes No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
06/16/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022220s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022220_trivaris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022220s000_SUMR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022220lbl.pdf

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