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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 021507

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NDA 021507 describes PREVACID NAPRAPAC 500 (COPACKAGED), which is a drug marketed by Takeda Pharms Na and is included in one NDA. Additional details are available on the PREVACID NAPRAPAC 500 (COPACKAGED) profile page.

The generic ingredient in PREVACID NAPRAPAC 500 (COPACKAGED) 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 021507

Tradename:	PREVACID NAPRAPAC 500 (COPACKAGED)
Applicant:	Takeda Pharms Na
Ingredient:	lansoprazole; naproxen
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL			Strength	15MG,N/A;N/A,250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 14, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL			Strength	15MG,N/A;N/A,375MG
Approval Date:	Nov 14, 2003	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL			Strength	15MG,N/A;N/A,500MG
Approval Date:	Nov 14, 2003	TE:		RLD:	No

Expired US Patents for NDA 021507

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Na	PREVACID NAPRAPAC 500 (COPACKAGED)	lansoprazole; naproxen	CAPSULE, DELAYED REL PELLETS, TABLET;ORAL	021507-004	Nov 14, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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