Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062423

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Dosage Form; Route of Administration: SOLUTION/DROPS; OTIC
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A062423
Product Number: 001
Approval Date: Aug 25, 1983
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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