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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050356

COLY-MYCIN S (COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE)
EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
Marketing Status: Prescription
Active Ingredient: COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
Proprietary Name: COLY-MYCIN S
Dosage Form; Route of Administration: SUSPENSION/DROPS; OTIC
Strength: EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050356
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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