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Last Updated: April 19, 2024

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 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 021428

Tradename:	PREVACID
Applicant:	Takeda Pharms Usa
Ingredient:	lansoprazole
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021428

Mechanism of Action	Proton Pump Inhibitors
Physiological Effect	Inhibition Gastric Acid Secretion

Medical Subject Heading (MeSH) Categories for 021428

Anti-Ulcer Agents
Proton Pump Inhibitors

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 107, LLC	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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL			Strength	15MG
Approval Date:	Aug 30, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL			Strength	30MG
Approval Date:	Aug 30, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021428

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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	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-002	Aug 30, 2002	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	PREVACID	lansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	021428-001	Aug 30, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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