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FDA NDA · NDA216264

BLUDIGO

indigotindisulfonate sodium

Sponsor: PROVEPHARM SAS

APPLICATION
NDA216264
TYPE
NDA
ORIGINAL APPROVAL
2022-07-08
LATEST ACTION
2023-04-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BLUDIGO · ReferencePrescription
INDIGOTINDISULFONATE SODIUM 40MG/5ML (8MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-04-14Labeling · Supplement 1 · standard — Label ↗AP
2022-07-08Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Letter ↗AP
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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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