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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050417

LUMI-SPORYN (BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: LUMI-SPORYN
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AT
Application Number: N050417
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: CASPER PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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