FDA Drug Approval, A062423, NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
FDA Drug Approval, A062423, NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
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Contents: Summary Basis of Approval
ANDA: 062423
Company: SANDOZ
Drug Name: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Active Ingredients: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Dosage Form/Route: SOLUTION/DROPS;OTIC
Action Date: 08/25/1983
Marketing Status: Prescription
Submission Classification: ORIG-1 TE Code: AT
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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