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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065349

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CEFADROXIL (CEFADROXIL/CEFADROXIL HEMIHYDRATE)
EQ 250MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: CEFADROXIL/CEFADROXIL HEMIHYDRATE
Proprietary Name: CEFADROXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 250MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065349
Product Number: 001
Approval Date: Apr 25, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
CEFADROXIL (CEFADROXIL/CEFADROXIL HEMIHYDRATE)
EQ 500MG BASE/5ML
Marketing Status: Prescription
Active Ingredient: CEFADROXIL/CEFADROXIL HEMIHYDRATE
Proprietary Name: CEFADROXIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 500MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065349
Product Number: 002
Approval Date: Apr 25, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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