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Serving leading biopharmaceutical companies globally:

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Colorcon
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Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061212

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NDA 061212 describes BACITRACIN, which is a drug marketed by Sagent Strides, Perrigo Co Tennessee, Fresenius Kabi Usa, Pharmacia And Upjohn, Pharmafair, Paddock Llc, Naska, Pharmaderm, Xellia Pharms Aps, Pfizer, Lilly, Combe, Apothekernes, Akorn, Bausch And Lomb, and Altana, and is included in twenty-two NDAs. It is available from eight suppliers. Additional details are available on the BACITRACIN profile page.

The generic ingredient in BACITRACIN is bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 061212

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

Pharmacology for NDA: 061212

Suppliers and Packaging for NDA: 061212

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACITRACIN
bacitracin
OINTMENT;OPHTHALMIC 061212 ANDA Paddock Laboratories, LLC 0574-4022 0574-4022-01 1 TUBE in 1 CARTON (0574-4022-01) > 1 g in 1 TUBE (0574-4022-11)
BACITRACIN
bacitracin
OINTMENT;OPHTHALMIC 061212 ANDA Paddock Laboratories, LLC 0574-4022 0574-4022-13 3 TUBE in 1 CARTON (0574-4022-13) > 1 g in 1 TUBE (0574-4022-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength500 UNITS/GM
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
McKesson
Cantor Fitzgerald
Novartis
Chinese Patent Office
US Department of Justice
Healthtrust
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McKinsey
Fuji

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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