APPLICATION
ANDA215012
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-25
LATEST ACTION
2025-09-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TACROLIMUSPrescription
TACROLIMUS EQ 5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 0.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 1MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-09-04Labeling · Supplement 1 · standardAP
2024-01-25UNKNOWN · Original · 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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