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FDA ANDA · ANDA211040

SIROLIMUS

Sponsor: NOVITIUM PHARMA

APPLICATION
ANDA211040
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-28
LATEST ACTION
2021-05-21
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SIROLIMUSPrescription
SIROLIMUS 1MG/ML · SOLUTION · ORAL

Approval history

2021-05-21Labeling · Supplement 4 · standardAP
2021-05-21Labeling · Supplement 3 · standardAP
2021-05-21Labeling · Supplement 1 · standardAP
2019-01-28UNKNOWN · 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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