APPLICATION
ANDA065461
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-10
LATEST ACTION
2024-02-07
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
2024-02-07Labeling · Supplement 38 · standardAP
2023-05-01Labeling · Supplement 36 · standardAP
2023-05-01Labeling · Supplement 37 · standardAP
2023-05-01Labeling · Supplement 35 · standardAP
2019-09-17Labeling · Supplement 32 · standardAP
2019-03-25Labeling · Supplement 30 · standardAP
2019-03-25Labeling · Supplement 29 · standardAP
2015-11-20Labeling · Supplement 25 · standardAP
2014-02-27Labeling · Supplement 23 · standardAP
2013-05-07Labeling · Supplement 18 · standardAP
2012-12-10Labeling · Supplement 12 · standardAP
2012-10-12Labeling · Supplement 11 · standardAP
2012-06-27Labeling · Supplement 10 · standardAP
2011-12-27Labeling · Supplement 9AP
2011-11-18Labeling · Supplement 8AP
2011-09-27Labeling · Supplement 6AP
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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