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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019525
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FML-S FLUOROMETHOLONE; SULFACETAMIDE SODIUM 0.1%;10% SUSPENSION/DROPS;OPHTHALMIC Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/10/2005 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf
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