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Generated: June 24, 2017

DrugPatentWatch Database Preview

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-four drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.

Summary for NDA: 021507

Tradename:
3
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS, TABLET;ORALStrength15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 14, 2003TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS, TABLET;ORALStrength15MG,N/A;N/A,375MG
Approval Date:Nov 14, 2003TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS, TABLET;ORALStrength15MG,N/A;N/A,500MG
Approval Date:Nov 14, 2003TE:RLD:No

Expired Orange Book Patents for NDA: 021507

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;ORAL021507-004Nov 14, 20035,433,959*PED► Subscribe
Takeda Pharms Na
PREVACID NAPRAPAC 500 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507-004Nov 14, 20034,628,098*PED► Subscribe
Takeda Pharms Na
PREVACID NAPRAPAC 500 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507-004Nov 14, 20035,093,132*PED► Subscribe
Takeda Pharms Na
PREVACID NAPRAPAC 500 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507-004Nov 14, 20035,045,321*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Citi
Teva
Boehringer Ingelheim
Harvard Business School
Cerilliant
Cantor Fitzgerald
Dow
Argus Health
QuintilesIMS
US Army

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