Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011340
Company: PHARM RES ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERUMENEX TROLAMINE POLYPEPTIDE OLEATE CONDENSATE 10% SOLUTION/DROPS;OTIC Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2002 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/11340s16lbl.pdf

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