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Last Updated: October 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065022


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NDA 065022 describes BACITRACIN ZINC AND POLYMYXIN B SULFATE, which is a drug marketed by Akorn, Bausch And Lomb, and Padagis Us, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the BACITRACIN ZINC AND POLYMYXIN B SULFATE profile page.

The generic ingredient in BACITRACIN ZINC AND POLYMYXIN B SULFATE is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
Summary for 065022
Pharmacology for NDA: 065022
Suppliers and Packaging for NDA: 065022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 065022 ANDA Paddock Laboratories, LLC 0574-4021 0574-4021-35 1 TUBE in 1 CARTON (0574-4021-35) > 3.5 g in 1 TUBE
BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 065022 ANDA RPK Pharmaceuticals, Inc. 53002-9270 53002-9270-1 3.5 g in 1 TUBE (53002-9270-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength500 UNITS/GM;10,000 UNITS/GM
Approval Date:Feb 27, 2002TE:ATRLD:No

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