Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065089

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AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN; CLAVULANATE POTASSIUM)
200MG/5ML;EQ 28.5MG 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: 200MG/5ML;EQ 28.5MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065089
Product Number: 001
Approval Date: May 25, 2004
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN; CLAVULANATE POTASSIUM)
400MG/5ML;EQ 57MG 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: 400MG/5ML;EQ 57MG BASE/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A065089
Product Number: 002
Approval Date: May 25, 2004
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information