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 five 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. Two suppliers are listed for this compound. 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. Two suppliers are 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: | 5 |
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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 12.5GM/50ML (250MG/ML) | ||||
| Approval Date: | Feb 14, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 7, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 10, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 29, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING | ||||||||
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