General MedicationsINTRAVENOUSStandard
BLUDIGO
INDIGOTINDISULFONATE SODIUM
Standard Dose
40MG/5ML (8MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BLUDIGO is listed in Drugs@FDA under application 216264 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient INDIGOTINDISULFONATE SODIUM Form and strength SOLUTION;INTRAVENOUS - 40MG/5ML (8MG/ML) Sponsor PROVEPHARM SAS Submission history Latest submission status date: 2023-04-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview BLUDIGO is listed in Drugs@FDA under application 216264 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient INDIGOTINDISULFONATE SODIUM Form and strength SOLUTION;INTRAVENOUS - 40MG/5ML (8MG/ML) Sponsor PROVEPHARM SAS Submission history Latest submission status date: 2023-04-14 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.