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FDA NDA · NDA210296

BAFIERTAM

monomethyl fumarate

Sponsor: BANNER LIFE SCIENCES

APPLICATION
NDA210296
TYPE
NDA
ORIGINAL APPROVAL
2020-04-28
LATEST ACTION
2024-09-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

BAFIERTAM · ReferencePrescription
MONOMETHYL FUMARATE 95MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-09-26Labeling · Supplement 7 · standard — Label ↗AP
2023-12-13Labeling · Supplement 6 · standard — Letter ↗AP
2023-12-13Labeling · Supplement 5 · standard — Letter ↗AP
2023-01-12Labeling · Supplement 4 · standard — Letter ↗AP
2020-04-28Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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