APPLICATION
ANDA213112
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-10
LATEST ACTION
2024-11-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TACROLIMUSPrescription
TACROLIMUS EQ 5MG BASE · CAPSULE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 0.5MG BASE · CAPSULE · ORAL
TACROLIMUSPrescription
TACROLIMUS EQ 1MG BASE · CAPSULE · ORAL
Approval history
2024-11-05Labeling · Supplement 12 · standardAP
2024-11-05Labeling · Supplement 7 · standardAP
2024-11-05Labeling · Supplement 4 · standardAP
2024-11-05Labeling · Supplement 9 · standardAP
2021-06-04Labeling · Supplement 1 · 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.
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