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FDA ANDA · ANDA207022

MYCOPHENOLATE MOFETIL

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA207022
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-22
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 250MG · CAPSULE · ORAL

Approval history

2026-07-29REMS · Supplement 7AP
2024-10-22UNKNOWN · Original · standardAP
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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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