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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206938

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CEFIXIME (CEFIXIME)
100MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFIXIME
Proprietary Name: CEFIXIME
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206938
Product Number: 001
Approval Date: Feb 6, 2017
Applicant Holder Full Name: BELCHER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CEFIXIME (CEFIXIME)
200MG/5ML
Marketing Status: Prescription
Active Ingredient: CEFIXIME
Proprietary Name: CEFIXIME
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 200MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206938
Product Number: 002
Approval Date: Feb 6, 2017
Applicant Holder Full Name: BELCHER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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