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FDA NDA · NDA216482

MYHIBBIN

mycophenolate mofetil

Sponsor: AZURITY

APPLICATION
NDA216482
TYPE
NDA
ORIGINAL APPROVAL
2024-05-01
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

MYHIBBIN · ReferencePrescription
MYCOPHENOLATE MOFETIL 200MG/ML · SUSPENSION · ORAL

Approval history

2026-07-29REMS · Supplement 5 — Letter ↗AP
2026-07-29Labeling · Supplement 6 · standard — Letter ↗AP
2025-06-27Labeling · Supplement 2 · standard — Letter ↗AP
2024-08-13REMS · Supplement 1 — Letter ↗AP
2024-05-01Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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