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LABETALOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2025-09-23

Drug application

FDA Application #

ANDA217949

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

MACLEODS PHARMS LTD

Manufacturer

Macleods Pharmaceuticals Limited

First approval

2025-09-23

Source

Authoritative

Drugs@FDA application overview

Machine

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