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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200563

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CIPROFLOXACIN (CIPROFLOXACIN)
250MG/5ML
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN
Proprietary Name: CIPROFLOXACIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 250MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200563
Product Number: 001
Approval Date: Mar 5, 2014
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CIPROFLOXACIN (CIPROFLOXACIN)
500MG/5ML
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN
Proprietary Name: CIPROFLOXACIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 500MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A200563
Product Number: 002
Approval Date: Mar 5, 2014
Applicant Holder Full Name: CHARTWELL LIFE MOLECULES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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