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FDA NDA · NDA206110

CASPOFUNGIN ACETATE

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA206110
TYPE
NDA
ORIGINAL APPROVAL
2016-12-30
LATEST ACTION
2021-04-01
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

CASPOFUNGIN ACETATEPrescription
CASPOFUNGIN ACETATE 50MG/VIAL · POWDER · INTRAVENOUS
CASPOFUNGIN ACETATEPrescription
CASPOFUNGIN ACETATE 70MG/VIAL · POWDER · INTRAVENOUS

Approval history

2021-04-01Labeling · Supplement 3 · standard — Label ↗AP
2018-06-28Labeling · Supplement 1 · standard — Label ↗AP
2016-12-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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