← FDA DRUG APPROVALS

FDA NDA · NDA022561

MAVENCLAD

cladribine

Sponsor: EMD SERONO INC

APPLICATION
NDA022561
TYPE
NDA
ORIGINAL APPROVAL
2019-03-29
LATEST ACTION
2026-05-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MAVENCLAD · ReferencePrescription
CLADRIBINE 10MG · TABLET · ORAL

Approval history

2026-05-14Labeling · Supplement 13 · standard — Letter ↗AP
2024-05-10Labeling · Supplement 11 · standard — Letter ↗AP
2024-02-07Labeling · Supplement 9 · standard — Label ↗AP
2023-12-06Labeling · Supplement 7 · standard — Letter ↗AP
2022-09-19Labeling · Supplement 6 · standard — Letter ↗AP
2019-03-29Type 3 - New Dosage Form · Original · standard — 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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