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Generated: May 20, 2019

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Details for New Drug Application (NDA): 021428

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NDA 021428 describes PREVACID, which is a drug marketed by Takeda Pharms Usa, Takeda Pharms Na, and Glaxosmithkline Cons, and is included in six NDAs. It is available from seven suppliers. There are five patents 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 021428
Tradename:PREVACID
Applicant:Takeda Pharms Usa
Ingredient:lansoprazole
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 021428
Mechanism of ActionProton Pump Inhibitors
Physiological EffectInhibition Gastric Acid Secretion
Medical Subject Heading (MeSH) Categories for 021428
Suppliers and Packaging for NDA: 021428
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 NDA Rebel Distributors Corp 21695-106 21695-106-15 15 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BOTTLE (21695-106-15)
PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 NDA Cardinal Health 55154-0253 55154-0253-0 10 BLISTER PACK in 1 BAG (55154-0253-0) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength15MG
Approval Date:Aug 30, 2002TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021428

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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