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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020511
Company: ULURU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APHTHASOL AMLEXANOX 5% PASTE;DENTAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/11/2002 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf
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