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FDA NDA · NDA204630

PROVAYBLUE

methylene blue

Sponsor: PROVEPHARM SAS

APPLICATION
NDA204630
TYPE
NDA
ORIGINAL APPROVAL
2016-04-08
LATEST ACTION
2024-12-02
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PROVAYBLUE · ReferencePrescription
METHYLENE BLUE 50MG/10ML (5MG/ML) · SOLUTION · INTRAVENOUS
PROVAYBLUE · ReferencePrescription
METHYLENE BLUE 10MG/2ML (5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-12-02Labeling · Supplement 26 · standard — Letter ↗AP
2024-02-05Labeling · Supplement 23 · standard — Letter ↗AP
2024-01-08Efficacy · Supplement 21 · standard — Label ↗AP
2023-11-02Labeling · Supplement 22 · standard — Label ↗AP
2022-08-18Labeling · Supplement 18 · standard — Letter ↗AP
2022-07-13Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2021-12-03Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2021-05-26Labeling · Supplement 11 · standard — Letter ↗AP
2021-05-21Labeling · Supplement 10 · standard — Letter ↗AP
2018-05-21Labeling · Supplement 6 · standard — Label ↗AP
2017-12-29Labeling · Supplement 5 · standard — Label ↗AP
2016-11-29Manufacturing (CMC) · Supplement 2 · standardAP
2016-04-08Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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