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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.
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.
Pharmacology for NDA: 204630
|Mechanism of Action||Oxidation-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.||0517-0125||0517-0125-05||5 AMPULE in 1 CARTON (0517-0125-05) > 2 mL in 1 AMPULE (0517-0125-01)|
|PROVAYBLUE||methylene blue||SOLUTION;INTRAVENOUS||204630||NDA||American Regent, Inc.||0517-0374||0517-0374-05||5 AMPULE in 1 CARTON (0517-0374-05) > 10 mL in 1 AMPULE (0517-0374-01)|
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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