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 one supplier. 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

Pharmacology for NDA: 020406

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

Medical Subject Heading (MeSH) Categories for 020406

Anti-Ulcer Agents
Proton Pump Inhibitors

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:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 10, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	30MG
Approval Date:	May 10, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020406

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-001	May 10, 1995	5,433,959*PED	⤷ Get Started Free
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	5,433,959*PED	⤷ Get Started Free
Takeda Pharms Usa	PREVACID	lansoprazole	CAPSULE, DELAYED REL PELLETS;ORAL	020406-002	May 10, 1995	5,026,560*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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