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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050824

OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN (AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE)
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Proprietary Name: OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
Dosage Form; Route of Administration: 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500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050824
Product Number: 001
Approval Date: Feb 8, 2011
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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