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OMEGA-3-ACID ETHYL ESTERS

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PURACAP PHARM LLC · Approved 2020-06-15

Drug application

FDA Application #
ANDA210093
Application type
Abbreviated New Drug Application (Generic)
Brand name
OMEGA-3-ACID ETHYL ESTERS
Generic name
OMEGA-3-ACID ETHYL ESTERS
Active ingredients
OMEGA-3-ACID ETHYL ESTERS
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
PURACAP PHARM LLC
Manufacturer
EPIC PHARMA, LLC
First approval
2020-06-15

Source

Authoritative
Drugs@FDA application overview
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