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LABETALOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EPIC PHARMA LLC · Approved 2020-09-30

Drug application

FDA Application #

ANDA212990

Application type

Abbreviated New Drug Application (Generic)

Brand name

LABETALOL HYDROCHLORIDE

Generic name

LABETALOL HYDROCHLORIDE

Active ingredients

LABETALOL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

EPIC PHARMA LLC

Manufacturer

Epic Pharma, LLC

First approval

2020-09-30

Source

Authoritative

Drugs@FDA application overview

Machine

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