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Details for New Drug Application (NDA): 065088

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NDA 065088 describes NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, which is a drug marketed by Bausch And Lomb, Perrigo Co Tennessee, and Akorn, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC is bacitracin zinc; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 065088

Pharmacology for NDA: 065088

Suppliers and Packaging for NDA: 065088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
bacitracin zinc; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 065088 ANDA Henry Schein Inc. 0404-7194 0404-7194-01 1 TUBE in 1 CARTON (0404-7194-01) > 3.5 g in 1 TUBE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
bacitracin zinc; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 065088 ANDA MWI 13985-607 13985-607-03 1 TUBE in 1 CARTON (13985-607-03) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Feb 6, 2004TE:ATRLD:No


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