APPLICATION
ANDA203153
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-30
LATEST ACTION
2025-02-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
TEMSIROLIMUSPrescription
TEMSIROLIMUS 25MG/ML (25MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-02-11Labeling · Supplement 4 · 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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