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Details for New Drug Application (NDA): 022222

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NDA 022222 describes ULTRESA, 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 ULTRESA profile page.

The generic ingredient in ULTRESA 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: 022222

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

Suppliers and Packaging for NDA: 022222

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ULTRESA
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL 022222 NDA Aptalis Pharma US, Inc 58914-003 58914-003-10 1 BOTTLE in 1 CARTON (58914-003-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
ULTRESA
pancrelipase (amylase;lipase;protease)
CAPSULE, DELAYED RELEASE;ORAL 022222 NDA Aptalis Pharma US, Inc 58914-005 58914-005-10 1 BOTTLE in 1 CARTON (58914-005-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength27,600USP UNITS;13,800USP UNITS;27,600USP 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:CAPSULE, DELAYED RELEASE;ORALStrength41,400USP UNITS;20,700USP UNITS;41,400USP UNITS
Approval Date:Mar 1, 2012TE:RLD:No
Regulatory Exclusivity Expiration:Mar 1, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength46,000USP UNITS;23,000USP UNITS;46,000USP UNITS
Approval Date:Mar 1, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 1, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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