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DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2020-09-15

Drug application

FDA Application #

ANDA211276

Application type

Abbreviated New Drug Application (Generic)

Brand name

DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

Generic name

DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE

Active ingredients

DEXTROSE; SODIUM CHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

BECTON DICKINSON AND COMPANY

First approval

2020-09-15

Source

Authoritative

Drugs@FDA application overview

Machine

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