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Details for New Drug Application (NDA): 064068

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NDA 064068 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Suppliers and Packaging for NDA: 064068

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 064068 ANDA Major Pharmaceuticals 0904-2995 0904-2995-38 1 TUBE in 1 CARTON (0904-2995-38) > 3.5 g in 1 TUBE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
OINTMENT;OPHTHALMIC 064068 ANDA Butler Animal Health Supply 11695-1406 11695-1406-6 1 TUBE in 1 CARTON (11695-1406-6) > 3.5 g in 1 TUBE

Summary 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:Oct 30, 1995TE:ATRLD:Yes


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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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