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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. Eight suppliers are listed for this compound. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

Summary for NDA: 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 59767-004-01 1 BOTTLE in 1 CARTON (59767-004-01) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
PERTZYE
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL 022175 NDA Digestive Care, Inc. 59767-008 59767-008-01 1 BOTTLE in 1 CARTON (59767-008-01) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Summary 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:No
Regulatory Exclusivity Expiration:May 17, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary 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
Regulatory Exclusivity Expiration:May 17, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary 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:No


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