APPLICATION
ANDA206651
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-30
LATEST ACTION
2024-07-12
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
2024-07-12Labeling · Supplement 7 · standardAP
2020-12-23Labeling · Supplement 1 · standardAP
2017-11-30UNKNOWN · 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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