APPLICATION
ANDA203859
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-31
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 17AP
2024-08-13REMS · Supplement 15AP
2023-03-08Labeling · Supplement 4 · standardAP
2023-03-08Labeling · Supplement 13 · standardAP
2023-03-08Labeling · Supplement 11 · standardAP
2021-08-11REMS · Supplement 9AP
2021-04-21REMS · Supplement 7AP
2021-01-15REMS · Supplement 3AP
2017-03-31UNKNOWN · OriginalAP
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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