Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018225
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMEX BUMETANIDE 1MG TABLET;ORAL Prescription AB Yes No
BUMEX BUMETANIDE 0.5MG TABLET;ORAL Prescription AB Yes No
BUMEX BUMETANIDE 2MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/08/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf
05/04/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
05/04/2017 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
01/21/2010 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf
10/29/2002 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
10/29/2002 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf

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