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Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Department of Justice
Express Scripts
Harvard Business School
Moodys
Johnson and Johnson
Chubb
Medtronic
Dow

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022175

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NDA 022175 describes PERTZYE, which is a drug marketed by Digestive Care Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PERTZYE profile page.

The generic ingredient in PERTZYE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.
Summary for 022175
Tradename:PERTZYE
Applicant:Digestive Care Inc
Ingredient:pancrelipase (amylase;lipase;protease)
Patents:0
Suppliers and Packaging for NDA: 022175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERTZYE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022175 NDA Digestive Care, Inc. 59767-004 N 59767-004-01
PERTZYE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022175 NDA Digestive Care, Inc. 59767-008 N 59767-008-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength30,250USP UNITS;8,000USP UNITS;28,750USP UNITS
Approval Date:May 17, 2012TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength60,500USP UNITS;16,000USP UNITS;57,500USP UNITS
Approval Date:May 17, 2012TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength15,125USP UNITS;4,000USP UNITS;14,375USP UNITS
Approval Date:Oct 6, 2016TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Teva
McKinsey
Boehringer Ingelheim
US Department of Justice
US Army
Baxter
Daiichi Sankyo
Medtronic

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