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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 203923

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NDA 203923 describes SODIUM THIOSULFATE, which is a drug marketed by Us Army and Hope Pharms and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SODIUM THIOSULFATE profile page.

The generic ingredient in SODIUM THIOSULFATE is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium thiosulfate profile page.
Summary for 203923
Tradename:SODIUM THIOSULFATE
Applicant:Hope Pharms
Ingredient:sodium thiosulfate
Patents:3
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923 NDA Hope Pharmaceuticals 60267-705 60267-705-50 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength12.5GM/50ML (250MG/ML)
Approval Date:Feb 14, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Patent:  Start TrialPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
Patent:  Start TrialPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?

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