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FOSPHENYTOIN SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2007-08-06

Drug application

FDA Application #

ANDA078052

Application type

Abbreviated New Drug Application (Generic)

Brand name

FOSPHENYTOIN SODIUM

Generic name

FOSPHENYTOIN SODIUM

Active ingredients

FOSPHENYTOIN SODIUM

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2007-08-06

Source

Authoritative

Drugs@FDA application overview

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