APPLICATION
ANDA204043
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2026-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETIL HYDROCHLORIDEPrescription
MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2026-07-29REMS · Supplement 18AP
2024-08-13REMS · Supplement 16AP
2024-07-03Labeling · Supplement 14 · standardAP
2024-07-03Labeling · Supplement 6 · standardAP
2024-07-03Labeling · Supplement 15 · standardAP
2021-08-11REMS · Supplement 11AP
2021-04-21REMS · Supplement 9AP
2021-01-15REMS · Supplement 8AP
2019-11-27Labeling · Supplement 3 · standardAP
2019-11-27Labeling · Supplement 1 · standardAP
2019-11-27Labeling · Supplement 4 · standardAP
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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