APPLICATION
ANDA212297
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-10
LATEST ACTION
2025-09-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TACROLIMUSPrescription
TACROLIMUS EQ 1MG BASE · CAPSULE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 5MG BASE · CAPSULE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 0.5MG BASE · CAPSULE · ORAL
Approval history
2025-09-26Labeling · Supplement 2 · standardAP
2025-09-26Labeling · Supplement 11 · standardAP
2020-11-10UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.