Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022523

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NDA 022523 describes PANCREAZE, which is a drug marketed by Vivus Inc and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the PANCREAZE profile page.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.
Summary for 022523
Tradename:PANCREAZE
Applicant:Vivus Inc
Ingredient:pancrelipase (amylase;lipase;protease)
Patents:5
Suppliers and Packaging for NDA: 022523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523 NDA Janssen Pharmaceuticals, Inc. 50458-347 50458-347-60 1 BOTTLE, GLASS in 1 CARTON (50458-347-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS
PANCREAZE pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022523 NDA VIVUS, Inc. 62541-401 62541-401-10 1 BOTTLE, GLASS in 1 CARTON (62541-401-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength24,600USP UNITS; 4,200USP UNITS; 14,200USP UNITS
Approval Date:Apr 12, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength61,500USP UNITS; 10,500USP UNITS; 35,500USP UNITS
Approval Date:Apr 12, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength98,400USP UNITS; 16,800USP UNITS; 56,800USP UNITS
Approval Date:Apr 12, 2010TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Express Scripts
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