Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207986

6% (60MG/ML)
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN
Proprietary Name: OTIPRIO
Dosage Form; Route of Administration: INJECTABLE, SUSPENSION; OTIC
Strength: 6% (60MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207986
Product Number: 001
Approval Date: Dec 10, 2015
Applicant Holder Full Name: ALK-ABELLO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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