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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050775

BIAXIN XL (CLARITHROMYCIN)
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLARITHROMYCIN
Proprietary Name: BIAXIN XL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050775
Product Number: 001
Approval Date: Mar 3, 2000
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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