.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Farmers Insurance
Citi
McKesson
Teva
Chubb
AstraZeneca
Novartis
Moodys

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022175

« Back to Dashboard

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 022175

Tradename:1
Applicant:1
Ingredient:1
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 59767-008-02 1 BOTTLE in 1 CARTON (59767-008-02) > 250 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:Yes
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:Yes


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
McKinsey
Farmers Insurance
Cerilliant
Argus Health
Healthtrust
Mallinckrodt
Teva
Moodys
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot