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Generated: November 17, 2018

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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. 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. 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
Generic Entry Opportunity Date for 204630
Generic Entry Date for 204630*:
Constraining patent/regulatory exclusivity:
FOR TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA.
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 204630

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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