BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Merck
Moodys
Fish and Richardson
US Department of Justice
Medtronic
Teva
Boehringer Ingelheim
Cipla
Citi

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050824

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NDA 050824 describes OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, which is a drug marketed by Gastroentero and is included in one NDA. It is available from one supplier. Additional details are available on the OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN profile page.

The generic ingredient in OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN is amoxicillin; clarithromycin; omeprazole. There are forty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; omeprazole profile page.
Summary for 050824
Tradename:OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
Applicant:Gastroentero
Ingredient:amoxicillin; clarithromycin; omeprazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824 NDA Cumberland Pharmaceuticals Inc. 66220-422 66220-422-02 10 BLISTER PACK in 1 CARTON (66220-422-02) > 1 KIT in 1 BLISTER PACK
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824 NDA Cumberland Pharmaceuticals Inc. 66220-422 66220-422-01 1 KIT in 1 BLISTER PACK (66220-422-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORALStrength500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG
Approval Date:Feb 8, 2011TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Federal Trade Commission
Julphar
Boehringer Ingelheim
Farmers Insurance
AstraZeneca
Harvard Business School
Novartis

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