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Last Updated: July 20, 2024

Details for New Drug Application (NDA): 020406


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NDA 020406 describes PREVACID, which is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Perrigo Pharma Intl, and is included in six NDAs. It is available from two suppliers. Additional details are available on the PREVACID profile page.

The generic ingredient in PREVACID is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
Summary for 020406
Tradename:PREVACID
Applicant:Takeda Pharms Usa
Ingredient:lansoprazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020406
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 020406
Suppliers and Packaging for NDA: 020406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 NDA Takeda Pharmaceuticals America, Inc. 64764-046 64764-046-06 5 BLISTER PACK in 1 TRAY (64764-046-06) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 NDA Takeda Pharmaceuticals America, Inc. 64764-046 64764-046-13 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-046-13)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 10, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength30MG
Approval Date:May 10, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020406

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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