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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050065

MAXITROL (DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: MAXITROL
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N050065
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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