Details for New Drug Application (NDA): 050824

NDA 050824 describes OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, which is a drug marketed by Cumberland 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-six 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:	Cumberland
Ingredient:	amoxicillin; clarithromycin; omeprazole
Patents:	0

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	66220-422-01	1 KIT in 1 BLISTER PACK (66220-422-01)
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

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Strength	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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