FDA Approval Activities for this Drug…

Bacitracin Injection, 50,000 units/vial, American Pharmaceutical Partners ANDA 65-116 12/3/02 Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Altana, ANDA 65-022 BACITRACIN Injection 50,000 UNITS/VIAL BACITRACIN AM PARTNERS 064153 BACITRACIN Injection 50,000 UNITS/VIAL BACIIM TEK 060733 BACITRACIN Injection 10,000 UNITS/VIAL BACITRACIN PHARMACIA AND UPJOHN 060733 BACITRACIN Injection 50,000 UNITS/VIAL BACITRACIN PHARMACIA AND UPJOHN 061212 BACITRACIN Ointment; Ophthalmic 500 UNITS/GM BACITRACIN Altana 061699 BACITRACIN Powder; For Compounding 5,000,000 UNITS/BOT BACITRACIN APOTHEKERNES 061580 BACITRACIN Powder; For Compounding 5,000,000 UNITS/BOT BACI-RX TEK 064068 AT BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE BAUSCH AND LOMB 050416 AT BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM CORTISPORIN MONARCH 050168 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Topical 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM CORTISPORIN MONARCH 060764 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACITRACIN-NEOMYCIN-POLYMYXIN Altana 064064 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BAUSCH AND LOMB 050417 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOSPORIN MONARCH 064028 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE Akorn 065022 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE Altana 064046 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE BAUSCH AND LOMB 061229 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM POLYSPORIN MONARCH 062166 BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE PHARMADERM Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment USP, Akorn, Inc. Cortisporin Ophthalmic Ointment, Monarch Pharmaceuticals

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