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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211068

AZITHROMYCIN (AZITHROMYCIN)
EQ 600MG BASE
Marketing Status: Prescription
Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 600MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211068
Product Number: 001
Approval Date: May 8, 2020
Applicant Holder Full Name: YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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