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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015296
Company: EUROFARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNALAR FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription AT Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/19/2012 SUPPL-64 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf
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