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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 three suppliers. Additional details are available on the PREVPAC profile page.

The generic ingredient in PREVPAC is amoxicillin; clarithromycin; lansoprazole. There are forty-three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; lansoprazole profile page.

Summary for NDA: 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 Physicians Total Care, Inc. 54868-4909 54868-4909-0 14 BLISTER PACK in 1 BOX (54868-4909-0) > 1 KIT in 1 BLISTER PACK
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 050757 NDA Takeda Pharmaceuticals America, Inc. 64764-702 64764-702-00 1 BLISTER PACK in 1 CARTON (64764-702-00) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage: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:ABRLD:Yes

Expired Orange Book 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;ORAL050757-001Dec 2, 19974,628,098*PED► subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 19975,433,959*PED► subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 19975,093,132*PED► subscribe
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