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Last Updated: November 13, 2024

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 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:RXDosage:SOLUTION;INTRAVENOUSStrength300MG/10ML (30MG/ML)
Approval Date:Feb 14, 2012TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 24, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Feb 10, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:SODIUM NITRITE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
Patent:⤷  Sign UpPatent Expiration:Feb 10, 2030Product Flag?YSubstance 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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