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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 063000

POLYMYXIN B SULFATE (POLYMYXIN B SULFATE)
EQ 500,000 UNITS BASE/VIAL
Marketing Status: Prescription
Active Ingredient: POLYMYXIN B SULFATE
Proprietary Name: POLYMYXIN B SULFATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500,000 UNITS BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A063000
Product Number: 001
Approval Date: Sep 30, 1994
Applicant Holder Full Name: ADRASTEA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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