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New Drug Application (NDA): 020696
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTIZOL FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/23/2020 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020696Orig1s006lbl.pdf
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