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DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2019-12-20

Drug application

FDA Application #

ANDA211190

Application type

Abbreviated New Drug Application (Generic)

Brand name

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Generic name

DEXTROSE MONOHYDRATE, SODIUM CHLORIDE

Active ingredients

DEXTROSE; SODIUM CHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2019-12-20

Source

Authoritative

Drugs@FDA application overview

Machine

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