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FDA ANDA · ANDA214283
MYCOPHENOLATE MOFETIL
mycophenolate mofetil hydrochloride
Sponsor: BPI LABS
APPLICATION
ANDA214283
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-01
LATEST ACTION
2026-07-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETIL HYDROCHLORIDEPrescription
MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2026-07-29REMS · Supplement 3AP
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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