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Last Updated: November 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 four 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 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
PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 NDA Takeda Pharmaceuticals America, Inc. 64764-543 64764-543-05 5 BLISTER PACK in 1 TRAY (64764-543-05) > 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021428
Tradename Dosage Ingredient NDA Submissiondate
PREVACID TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL lansoprazole 021428 2006-12-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORALStrength15MG
Approval Date:Aug 30, 2002TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent 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 021428-001 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-001 Aug 30, 2002   Start Trial   Start Trial
Takeda Pharms Usa PREVACID lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428-002 Aug 30, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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