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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 050757


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NDA 050757 describes PREVPAC (COPACKAGED), which is a drug marketed by Takeda Pharms Usa and is included in one NDA. Additional details are available on the PREVPAC (COPACKAGED) profile page.

The generic ingredient in PREVPAC (COPACKAGED) is amoxicillin; clarithromycin; lansoprazole. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.
Summary for 050757

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORALStrength500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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 (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;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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