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ZENPEP

BLA · Biologics License Application · Sponsor: EURAND PHARMA LTD · Approved 2009-08-27

Drug application

FDA Application #

BLA022210

Application type

Biologics License Application

Brand name

ZENPEP

Generic name

PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE

Active ingredients

PANCRELIPASE (AMYLASE; LIPASE; PROTEASE)

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

EURAND PHARMA LTD

Manufacturer

Aimmune Therapeutics, Inc.

First approval

2009-08-27

Source

Authoritative

Drugs@FDA application overview

Machine

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