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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 022327


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NDA 022327 describes PREVACID 24 HR, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from one supplier. Additional details are available on the PREVACID 24 HR profile page.

The generic ingredient in PREVACID 24 HR is lansoprazole. There are fifty-six drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the lansoprazole profile page.
Summary for 022327
Tradename:PREVACID 24 HR
Applicant:Perrigo Pharma Intl
Ingredient:lansoprazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022327
Suppliers and Packaging for NDA: 022327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVACID 24 HR lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 022327 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0067-6286 0067-6286-14 1 BOTTLE in 1 CARTON (0067-6286-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
PREVACID 24 HR lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 022327 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0067-6286 0067-6286-28 2 BOTTLE in 1 PACKAGE, COMBINATION (0067-6286-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
Approval Date:May 18, 2009TE:RLD:Yes

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