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Generated: August 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050757

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NDA 050757 describes PREVPAC, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the PREVPAC profile page.

The generic ingredient in PREVPAC is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 050757
Tradename:PREVPAC
Applicant:Takeda Pharms Usa
Ingredient:amoxicillin; clarithromycin; lansoprazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050757
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757 NDA Takeda Pharmaceuticals America, Inc. 64764-702 N 64764-702-01
PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-418 N 66993-418-64

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORALStrength500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG
Approval Date:Dec 2, 1997TE:RLD:Yes

Expired US Patents for NDA 050757

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757-001 Dec 2, 1997 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757-001 Dec 2, 1997 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757-001 Dec 2, 1997 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757-001 Dec 2, 1997 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa PREVPAC amoxicillin; clarithromycin; lansoprazole CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757-001 Dec 2, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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