Details for New Drug Application (NDA): 201444
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NDA 201444 describes NITHIODOTE, which is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the NITHIODOTE profile page.
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.
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: | ⤷ Subscribe | Patent Expiration: | Jul 7, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION | ||||||||
| Patent: | ⤷ Subscribe | 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: | ⤷ Subscribe | 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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