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New Drug Application (NDA): 020613
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALPHAGAN BRIMONIDINE TARTRATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/23/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020613s031lbl.pdf
12/20/2001 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf
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