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Chinese Patent Office
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Generated: October 18, 2017

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

The generic ingredient in PREVPAC is amoxicillin; clarithromycin; lansoprazole. There are forty-four 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:
1
Applicant:
1
Ingredient:
1
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 64764-702-01 14 BLISTER PACK in 1 BOX (64764-702-01) > 1 KIT in 1 BLISTER PACK (64764-702-11)

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, 1997► Subscribe► Subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 1997► Subscribe► Subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 1997► Subscribe► Subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 1997► Subscribe► Subscribe
Takeda Pharms Usa
PREVPAC
amoxicillin; clarithromycin; lansoprazole
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL050757-001Dec 2, 1997► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Queensland Health
Medtronic
UBS
Colorcon
Citi
AstraZeneca
Novartis
Federal Trade Commission
Deloitte

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