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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 Perrigo Co Tennessee, Akorn, and Bausch And Lomb, 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 NDA: 065022

Tradename:
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Applicant:
Perrigo Co Tennessee
Ingredient:
bacitracin zinc; polymyxin b sulfate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065022

Ingredient-typePolymyxins
Physiological EffectDecreased Cell Wall Synthesis & Repair

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 E. FOUGERA & CO., A division of Nycomed US Inc. 0168-0273 0168-0273-38 3.5 g in 1 TUBE (0168-0273-38)
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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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