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ORAPRED ODT

NDA · New Drug Application · Sponsor: ADVANZ PHARMA · Approved 2006-06-01

Drug application

FDA Application #

NDA021959

Application type

New Drug Application

Brand name

ORAPRED ODT

Generic name

PREDNISOLONE SODIUM PHOSPHATE

Active ingredients

PREDNISOLONE SODIUM PHOSPHATE

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Marketing status

Prescription

Sponsor

ADVANZ PHARMA

Manufacturer

Advanz Pharma (US) Corp.

First approval

2006-06-01

Source

Authoritative

Drugs@FDA application overview

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