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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050201

OPHTHOCORT (CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE)
10MG/GM;5MG/GM;10,000 UNITS/GM
Marketing Status: Discontinued
Active Ingredient: CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE
Proprietary Name: OPHTHOCORT
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 10MG/GM;5MG/GM;10,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050201
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PARKEDALE PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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