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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021537

CIPRODEX (CIPROFLOXACIN; DEXAMETHASONE)
0.3%;0.1%
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN; DEXAMETHASONE
Proprietary Name: CIPRODEX
Dosage Form; Route of Administration: SUSPENSION/DROPS; OTIC
Strength: 0.3%;0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021537
Product Number: 001
Approval Date: Jul 18, 2003
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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