Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062822

PEDIOTIC (HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: PEDIOTIC
Dosage Form; Route of Administration: SUSPENSION/DROPS; OTIC
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A062822
Product Number: 001
Approval Date: Sep 29, 1987
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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