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Details for New Drug Application (NDA): 022542

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NDA 022542 describes VIOKACE, which is a drug marketed by Forest Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the VIOKACE profile page.

The generic ingredient in VIOKACE 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: 022542

Tradename:
VIOKACE
Applicant:
Forest Labs Inc
Ingredient:
pancrelipase (amylase;lipase;protease)
Patents:0

Suppliers and Packaging for NDA: 022542

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIOKACE
pancrelipase (amylase;lipase;protease)
TABLET;ORAL 022542 NDA Aptalis Pharma US, Inc 58914-112 58914-112-10 1 BOTTLE in 1 CARTON (58914-112-10) > 100 TABLET in 1 BOTTLE
VIOKACE
pancrelipase (amylase;lipase;protease)
TABLET;ORAL 022542 NDA Aptalis Pharma US, Inc 58914-117 58914-117-10 1 BOTTLE in 1 CARTON (58914-117-10) > 100 TABLET in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength39,150USP UNITS;10,440USP UNITS;39,150USP UNITS
Approval Date:Mar 1, 2012TE:RLD:No
Regulatory Exclusivity Expiration:Mar 1, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength78,300USP UNITS;20,880USP UNITS;78,300USP UNITS
Approval Date:Mar 1, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 1, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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