← FDA Drug Approvals (Drugs@FDA)

ENTECAVIR

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRIGHTGENE · Approved 2019-09-25

Drug application

FDA Application #

ANDA212126

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENTECAVIR

Generic name

ENTECAVIR

Active ingredients

ENTECAVIR

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

BRIGHTGENE

Manufacturer

EPIC PHARMA, LLC

First approval

2019-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

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