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FDA ANDA · ANDA207486

EVEROLIMUS

Sponsor: HIKMA

APPLICATION
ANDA207486
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-08
LATEST ACTION
2021-11-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EVEROLIMUSPrescription
EVEROLIMUS 10MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 7.5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 2.5MG · TABLET · ORAL

Approval history

2021-11-23UNKNOWN · Original · standardAP
2020-06-08UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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