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Last Updated: January 19, 2020

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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 is one patent 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
Applicant:Hope Pharms
Ingredient:sodium nitrite
Formulation / Manufacturing:see details
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:  Start TrialPatent Expiration:Dec 24, 2031Product Flag?YSubstance Flag?YDelist Request?

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