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ICOSAPENT ETHYL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2021-06-30

Drug application

FDA Application #
ANDA209437
Application type
Abbreviated New Drug Application (Generic)
Brand name
ICOSAPENT ETHYL
Generic name
ICOSAPENT ETHYL
Active ingredients
ICOSAPENT ETHYL
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
APOTEX
Manufacturer
Apotex Corp
First approval
2021-06-30

Source

Authoritative
Drugs@FDA application overview
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