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Fuji
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Harvard Business School
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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065213

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NDA 065213 describes NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, which is a drug marketed by Akorn and Bausch And Lomb and is included in two NDAs. It is available from seven suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE is bacitracin zinc; hydrocortisone; neomycin sulfate; 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; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Pharmacology for NDA: 065213
Suppliers and Packaging for NDA: 065213
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 065213 ANDA Henry Schein Inc. 0404-7195 N 0404-7195-01
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 065213 ANDA MWI 13985-608 N 13985-608-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Jul 25, 2012TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Federal Trade Commission
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