Details for New Drug Application (NDA): 203922
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The generic ingredient in SODIUM NITRITE is sodium nitrite. 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 profile page.
Summary for 203922
Tradename: | SODIUM NITRITE |
Applicant: | Hope Pharms |
Ingredient: | sodium nitrite |
Patents: | 2 |
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: | 8,568,793 | Patent Expiration: | Dec 24, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | 9,687,506 | Patent Expiration: | Feb 10, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION | ||||||||
Patent: | 9,687,506 | 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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