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 six patents protecting this drug. Additional details are available on the SODIUM THIOSULFATE profile page.
The generic ingredient in SODIUM THIOSULFATE is sodium thiosulfate. There is one drug master file entry 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 is one drug master file entry 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: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203923
Generic Entry Date for 203923*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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: | ⤷ Start Trial | Patent Expiration: | Jul 7, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION | ||||||||
| Patent: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Feb 10, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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