Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050168

CORTISPORIN (BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: CORTISPORIN
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050168
Product Number: 002
Approval Date: May 4, 1984
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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