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PANTOPRAZOLE SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2024-08-01

Drug application

FDA Application #

ANDA216021

Application type

Abbreviated New Drug Application (Generic)

Brand name

PANTOPRAZOLE SODIUM

Generic name

PANTOPRAZOLE SODIUM

Active ingredients

PANTOPRAZOLE SODIUM

Dosage form

POWDER

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2024-08-01

Source

Authoritative

Drugs@FDA application overview

Machine

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