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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202588

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) (AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE)
500MG;500MG;30MG
Marketing Status: Prescription
Active Ingredient: AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Proprietary Name: LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL
Strength: 500MG;500MG;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202588
Product Number: 001
Approval Date: Mar 4, 2014
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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