Details for New Drug Application (NDA): 021281

NDA 021281 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 021281

Tradename:	PREVACID
Applicant:	Takeda Pharms Na
Ingredient:	lansoprazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 021281

Anti-Ulcer Agents

Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	15MG/PACKET
Approval Date:	May 3, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION, DELAYED RELEASE;ORAL			Strength	30MG/PACKET
Approval Date:	May 3, 2001	TE:		RLD:	No

Expired US Patents for NDA 021281

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-001	May 3, 2001
Takeda Pharms Na	PREVACID	lansoprazole	FOR SUSPENSION, DELAYED RELEASE;ORAL	021281-002	May 3, 2001

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