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CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2023-09-15

Drug application

FDA Application #

ANDA216969

Application type

Abbreviated New Drug Application (Generic)

Brand name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Generic name

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

Active ingredients

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Inc.

First approval

2023-09-15

Source

Authoritative

Drugs@FDA application overview

Machine

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