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.
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
| Tradename: | PREVPAC (COPACKAGED) |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | amoxicillin; clarithromycin; lansoprazole |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 2, 1997 | TE: | 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 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | PREVPAC (COPACKAGED) | amoxicillin; clarithromycin; lansoprazole | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 050757-001 | Dec 2, 1997 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | PREVPAC (COPACKAGED) | amoxicillin; clarithromycin; lansoprazole | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 050757-001 | Dec 2, 1997 | ⤷ Subscribe | ⤷ Subscribe |
| Takeda Pharms Usa | PREVPAC (COPACKAGED) | amoxicillin; clarithromycin; lansoprazole | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | 050757-001 | Dec 2, 1997 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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