← FDA DRUG APPROVALS

FDA NDA · NDA205750

CHOLBAM

cholic acid

Sponsor: MIRUM

APPLICATION
NDA205750
TYPE
NDA
ORIGINAL APPROVAL
2015-03-17
LATEST ACTION
2023-03-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CHOLBAM · ReferencePrescription
CHOLIC ACID 50MG · CAPSULE · ORAL
CHOLBAM · ReferencePrescription
CHOLIC ACID 250MG · CAPSULE · ORAL

Approval history

2023-03-30Labeling · Supplement 5 · standard — Letter ↗AP
2020-10-22Labeling · Supplement 3 · standard — Letter ↗AP
2015-03-17Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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