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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylene blue profile page.
The generic ingredient in PROVAYBLUE is methylene blue. There is one drug master file entry for this compound. Twelve suppliers are 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 |
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. | 0517-0371 | 0517-0371-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Apr 8, 2016 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 8, 2027 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE CLINICAL STUDIES SECTION TO FULFILL A POST-MARKETING REQUIREMENT | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/2ML (5MG/ML) | ||||
| Approval Date: | Jul 18, 2019 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 8, 2027 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE CLINICAL STUDIES SECTION TO FULFILL A POST-MARKETING REQUIREMENT | ||||||||
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