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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062166

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE (BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A062166
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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