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McKinsey
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Generated: May 23, 2018

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-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
Formulation / Manufacturing:see details

Profile 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PELLETS, TABLET;ORALStrength15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile 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

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

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
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US Army
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Cantor Fitzgerald
Mallinckrodt

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