← FDA DRUG APPROVALS

FDA NDA · NDA215935

TARPEYO

budesonide

Sponsor: CALLIDITAS

APPLICATION
NDA215935
TYPE
NDA
ORIGINAL APPROVAL
2021-12-15
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

TARPEYO · ReferencePrescription
BUDESONIDE 4MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-06-05Labeling · Supplement 5 · standard — Label ↗AP
2024-06-05Labeling · Supplement 4 · standardAP
2023-12-20Efficacy · Supplement 3 · priority — Label ↗AP
2021-12-15Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗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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