Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209371

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AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN; CLAVULANATE POTASSIUM)
125MG/5ML;EQ 31.25MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: AMOXICILLIN; CLAVULANATE POTASSIUM
Proprietary Name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML;EQ 31.25MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209371
Product Number: 001
Approval Date: Apr 19, 2019
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN; CLAVULANATE POTASSIUM)
250MG/5ML;EQ 62.5MG BASE/5ML
Marketing Status: Prescription

Active Ingredient: AMOXICILLIN; CLAVULANATE POTASSIUM
Proprietary Name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML;EQ 62.5MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209371
Product Number: 002
Approval Date: Apr 19, 2019
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information