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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 061578

100,000,000 UNITS/BOT
Marketing Status: Discontinued
Active Ingredient: POLYMYXIN B SULFATE
Proprietary Name: POLY-RX
Dosage Form; Route of Administration: POWDER; FOR RX COMPOUNDING
Strength: 100,000,000 UNITS/BOT
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A061578
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: X GEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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