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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 064064

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC (BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AT
Application Number: A064064
Product Number: 001
Approval Date: Oct 30, 1995
Applicant Holder Full Name: BAUSCH AND LOMB PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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