Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022048
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIESENCE TRIAMCINOLONE ACETONIDE 40MG/ML (40MG/ML) INJECTABLE;INTRAVITREAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/2007 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022048s000, 022223s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022048s000_022223s000_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/29/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf

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