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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065261

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CEFPROZIL (CEFPROZIL)
125MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFPROZIL
Proprietary Name: CEFPROZIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 125MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065261
Product Number: 001
Approval Date: Dec 19, 2005
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
CEFPROZIL (CEFPROZIL)
250MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFPROZIL
Proprietary Name: CEFPROZIL
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A065261
Product Number: 002
Approval Date: Dec 19, 2005
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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