Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203923
Company: HOPE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM THIOSULFATE SODIUM THIOSULFATE 12.5GM/50ML (250MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/14/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203923s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203923s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923_sodium_thiosulfate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203923Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203923s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203923Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203923s001lbl.pdf
02/14/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203923s000lbl.pdf

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