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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.
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.
*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:||RX||Dosage:||SOLUTION;INTRAVENOUS||Strength||50MG/10ML (5MG/ML)|
|Approval Date:||Apr 8, 2016||TE:||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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