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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Deloitte
Covington
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Cipla
Fuji
Julphar
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022210

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NDA 022210 describes ZENPEP, which is a drug marketed by Forest Labs Inc and is included in one NDA. It is available from three suppliers. There are seven patents protecting this drug. Additional details are available on the ZENPEP profile page.

The generic ingredient in ZENPEP 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 022210
Tradename:ZENPEP
Applicant:Forest Labs Inc
Ingredient:pancrelipase (amylase;lipase;protease)
Patents:7
Suppliers and Packaging for NDA: 022210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 NDA Allergan, Inc. 0023-6110 N 0023-6110-01
ZENPEP pancrelipase (amylase;lipase;protease) CAPSULE, DELAYED RELEASE;ORAL 022210 NDA Allergan, Inc. 0023-6111 N 0023-6111-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength24,000USP UNITS;5,000USP UNITS;17,000USP UNITS
Approval Date:Aug 27, 2009TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 20, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 20, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 20, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER CONDITIONS

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
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