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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Teva
Argus Health
US Army
Chinese Patent Office
Fuji
Johnson and Johnson
Merck
US Department of Justice

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204630

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NDA 204630 describes PROVAYBLUE, which is a drug marketed by Provepharm Sas and is included in one NDA. It is available from one supplier. Additional details are available on the PROVAYBLUE profile page.

The generic ingredient in PROVAYBLUE is methylene blue. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylene blue profile page.
Summary for 204630
Tradename:PROVAYBLUE
Applicant:Provepharm Sas
Ingredient:methylene blue
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204630
Mechanism of ActionOxidation-Reduction Activity
Medical Subject Heading (MeSH) Categories for 204630
Suppliers and Packaging for NDA: 204630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROVAYBLUE methylene blue SOLUTION;INTRAVENOUS 204630 NDA American Regent, Inc. 0517-0374 N 0517-0374-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Apr 8, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 8, 2023
Regulatory Exclusivity Use:FOR TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA.

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Farmers Insurance
AstraZeneca
Merck
Deloitte
Accenture
Daiichi Sankyo
Argus Health

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