Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022225
Company: ORGANON SUB MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRIDION SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
BRIDION SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/25/2021 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s008lbl.pdf
01/22/2021 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf
01/22/2021 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf
06/09/2020 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022225s006lbl.pdf
10/24/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022225s001lbl.pdf
12/15/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf

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