APPLICATION
ANDA090596
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-17
LATEST ACTION
2025-02-20
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
2025-02-20Labeling · Supplement 27 · standardAP
2025-02-20Labeling · Supplement 23 · standardAP
2025-02-20Labeling · Supplement 24 · standardAP
2025-02-20Labeling · Supplement 20 · standardAP
2024-09-20Manufacturing (CMC) · Supplement 28 · unknownAP
2020-12-03Labeling · Supplement 17 · standardAP
2020-12-03Labeling · Supplement 15 · standardAP
2020-12-03Labeling · Supplement 12 · standardAP
2020-12-03Labeling · Supplement 10 · standardAP
2015-12-15Labeling · Supplement 6 · standardAP
2010-09-17OriginalAP
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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