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Daiichi Sankyo
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Deloitte
Julphar
UBS
Teva
Baxter
Cantor Fitzgerald
AstraZeneca

Generated: June 23, 2018

DrugPatentWatch Database Preview

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 four 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 twenty-six 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:4
Formulation / Manufacturing:see details
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 N 60267-812-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUSStrength300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)
Approval Date:Jan 14, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 14, 2018
Regulatory Exclusivity Use:FOR SEQUENTIAL USE FOR THE TREATMENT OF CYANIDE POISONING THAT IS JUDGED TO BE LIFE-THREATENING
Patent:➤ Sign UpPatent Expiration:Mar 29, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Patent:➤ Sign UpPatent Expiration:Dec 24, 2031Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Federal Trade Commission
McKinsey
Healthtrust
QuintilesIMS
Chinese Patent Office
UBS
Johnson and Johnson

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