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BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2021-11-04

Drug application

FDA Application #

ANDA215562

Application type

Abbreviated New Drug Application (Generic)

Brand name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Generic name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Active ingredients

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2021-11-04

Source

Authoritative

Drugs@FDA application overview

Machine

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