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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 050824

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NDA 050824 describes OMECLAMOX-PAK, which is a drug marketed by Cumberland and is included in one NDA. Additional details are available on the OMECLAMOX-PAK profile page.

The generic ingredient in OMECLAMOX-PAK is amoxicillin; clarithromycin; omeprazole. There are forty-six drug master file entries for this compound. Additional details are available on the amoxicillin; clarithromycin; omeprazole profile page.

Summary for 050824

Tradename:	OMECLAMOX-PAK
Applicant:	Cumberland
Ingredient:	amoxicillin; clarithromycin; omeprazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL			Strength	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 8, 2011	TE:		RLD:	Yes

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