APPLICATION
ANDA211212
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-18
LATEST ACTION
2023-07-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
SIROLIMUSPrescription
SIROLIMUS 1MG/ML · SOLUTION · ORAL
Approval history
2023-07-28Labeling · Supplement 1 · standardAP
2023-07-28Labeling · Supplement 4 · standardAP
2019-10-18UNKNOWN · 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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