You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 062488


✉ Email this page to a colleague

« Back to Dashboard


NDA 062488 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amring Pharms, Bausch And Lomb, and Sandoz, and is included in six NDAs. It is available from eleven suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Pharmacology for NDA: 062488
Suppliers and Packaging for NDA: 062488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062488 ANDA RPK Pharmaceuticals, Inc. 53002-9001 53002-9001-1 10 mL in 1 BOTTLE, PLASTIC (53002-9001-1)
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062488 ANDA Sandoz Inc. 61314-645 61314-645-11 10 mL in 1 BOTTLE, PLASTIC (61314-645-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Nov 6, 1985TE:ATRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.