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DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2020-08-26

Drug application

FDA Application #
ANDA211194
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
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
Fresenius Kabi USA, LLC
First approval
2020-08-26

Source

Authoritative
Drugs@FDA application overview
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