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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 two suppliers. 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-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amoxicillin; clarithromycin; omeprazole profile page.

Summary for NDA: 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 Pernix Therapeutics, LLC 65224-707 65224-707-11 10 BLISTER PACK in 1 CARTON (65224-707-11) > 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)

Summary 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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