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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Colorcon
Fish and Richardson
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Citi
US Department of Justice
Dow
Federal Trade Commission

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064028

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NDA 064028 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 ten 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. Ten suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
Summary for 064028
Tradename:BACITRACIN ZINC AND POLYMYXIN B SULFATE
Applicant:Akorn
Ingredient:bacitracin zinc; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064028
Ingredient-typePolymyxins
Physiological EffectDecreased Cell Wall Synthesis & Repair
Suppliers and Packaging for NDA: 064028
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 064028 ANDA Akorn, Inc. 17478-238 N 17478-238-35
BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc; polymyxin b sulfate OINTMENT;OPHTHALMIC 064028 ANDA Rebel Distributors Corp. 21695-156 E 21695-156-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength500 UNITS/GM;10,000 UNITS/GM
Approval Date:Jan 30, 1995TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Medtronic
Citi
UBS
Farmers Insurance
Mallinckrodt
US Army
McKesson
Daiichi Sankyo

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