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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019270
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2006 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf
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