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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:
PREVACID NAPRAPAC 250 (COPACKAGED)
Applicant:
Takeda Pharms Na
Ingredient:
lansoprazole; naproxen
Patents:0
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PELLETS, TABLET;ORALStrength15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

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, 20034,628,098*PED► subscribe
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, 20035,093,132*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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