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Last Updated: August 10, 2022

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 three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. 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 Action Proton 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 PD-Rx Pharmaceuticals, Inc. 55289-704 55289-704-07 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-704-07)
PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 NDA PD-Rx Pharmaceuticals, Inc. 55289-704 55289-704-14 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-704-14)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength15MG
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 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-001 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa PREVACID lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406-002 May 10, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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