Details for New Drug Application (NDA): 201444
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The generic ingredient in NITHIODOTE is sodium nitrite; 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 nitrite; sodium thiosulfate profile page.
Summary for 201444
Tradename: | NITHIODOTE |
Applicant: | Hope Pharms |
Ingredient: | sodium nitrite; sodium thiosulfate |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 201444
Generic Entry Date for 201444*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, SOLUTION;INTRAVENOUS, 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: 201444
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444 | NDA | Hope Pharmaceuticals | 60267-812 | 60267-812-00 | 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | Strength | 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) | ||||
Approval Date: | Jan 14, 2011 | 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: | 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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