Details for New Drug Application (NDA): 203922
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NDA 203922 describes SODIUM NITRITE, which is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SODIUM NITRITE profile page.
The generic ingredient in SODIUM NITRITE is sodium nitrite. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.
The generic ingredient in SODIUM NITRITE is sodium nitrite. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.
Summary for 203922
| Tradename: | SODIUM NITRITE |
| Applicant: | Hope Pharms |
| Ingredient: | sodium nitrite |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203922
Generic Entry Date for 203922*:
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.
Medical Subject Heading (MeSH) Categories for 203922
Suppliers and Packaging for NDA: 203922
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922 | NDA | Hope Pharmaceuticals | 60267-311 | 60267-311-10 | 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 300MG/10ML (30MG/ML) | ||||
| Approval Date: | Feb 14, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 24, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 10, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 10, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | SODIUM NITRITE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM THIOSULFATE FOR THE TREATMENT OF ACUTE CYANIDE POISONING | ||||||||
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