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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065259

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CEFDINIR (CEFDINIR)
125MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFDINIR
Proprietary Name: CEFDINIR
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065259
Product Number: 001
Approval Date: May 31, 2006
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
CEFDINIR (CEFDINIR)
250MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFDINIR
Proprietary Name: CEFDINIR
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065259
Product Number: 002
Approval Date: May 7, 2007
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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