APPLICATION
ANDA201578
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-27
LATEST ACTION
2023-08-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIROLIMUSPrescription
SIROLIMUS 1MG · TABLET · ORAL
SIROLIMUSPrescription
SIROLIMUS 2MG · TABLET · ORAL
Approval history
2023-08-31Labeling · Supplement 9 · standardAP
2023-08-31Labeling · Supplement 7 · standardAP
2023-08-31Labeling · Supplement 15 · standardAP
2023-08-31Labeling · Supplement 8 · standardAP
2023-08-31Labeling · Supplement 6 · standardAP
2023-08-31Labeling · Supplement 10 · standardAP
2016-01-14Labeling · Supplement 1 · standardAP
2016-01-14Labeling · Supplement 2 · standardAP
2014-10-27Not Applicable · OriginalAP
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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