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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 064028

BACITRACIN ZINC AND POLYMYXIN B SULFATE (BACITRACIN ZINC; POLYMYXIN B SULFATE)
500 UNITS/GM;10,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: BACITRACIN ZINC; POLYMYXIN B SULFATE
Proprietary Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 500 UNITS/GM;10,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A064028
Product Number: 001
Approval Date: Jan 30, 1995
Applicant Holder Full Name: SAPTALIS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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