← FDA Drug Approvals (Drugs@FDA)

PERTZYE

BLA · Biologics License Application · Sponsor: DIGESTIVE CARE INC · Approved 2012-05-17

Drug application

FDA Application #

BLA022175

Application type

Biologics License Application

Brand name

PERTZYE

Generic name

PANCRELIPASE

Active ingredients

PANCRELIPASE (AMYLASE; LIPASE; PROTEASE)

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

DIGESTIVE CARE INC

Manufacturer

Digestive Care, Inc.

First approval

2012-05-17

Source

Authoritative

Drugs@FDA application overview

Machine

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