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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064046

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NDA 064046 describes BACITRACIN ZINC AND POLYMYXIN B SULFATE, which is a drug marketed by Akorn, Bausch And Lomb, and Perrigo Co Tennessee, and is included in three NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.

Summary for 064046

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 064046

Ingredient-typePolymyxins
Physiological EffectDecreased Cell Wall Synthesis & Repair

Suppliers and Packaging for NDA: 064046

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 064046 ANDA Bausch & Lomb Incorporated 24208-555 24208-555-55 1 TUBE in 1 CARTON (24208-555-55) > 3.5 g in 1 TUBE
BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 064046 ANDA Rebel Distributors Corp 42254-154 42254-154-35 1 TUBE in 1 CARTON (42254-154-35) > 3.5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength500 UNITS/GM;10,000 UNITS/GM
Approval Date:Jan 26, 1995TE:ATRLD:No


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