APPLICATION
ANDA200744
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-09
LATEST ACTION
2023-06-02
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
TACROLIMUSPrescription
TACROLIMUS 0.1% · OINTMENT · TOPICAL
TACROLIMUSPrescription
TACROLIMUS 0.03% · OINTMENT · TOPICAL
Approval history
2023-06-02Labeling · Supplement 11 · standardAP
2015-04-29Manufacturing (CMC) · Supplement 1 · unknownAP
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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