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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209044

AZITHROMYCIN (AZITHROMYCIN)
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209044
Product Number: 001
Approval Date: Dec 7, 2018
Applicant Holder Full Name: SUNSHINE LAKE PHARMA CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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