Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050218

CORTISPORIN (HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: CORTISPORIN
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050218
Product Number: 001
Approval Date: Aug 9, 1985
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Prescription
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