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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 064047


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NDA 064047 describes NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, which is a drug marketed by Bausch And Lomb, Ipharm, Nordic Pharma, and Watson Labs, and is included in four NDAs. It is available from two suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN profile page.

The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN is gramicidin; neomycin sulfate; polymyxin b sulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gramicidin; neomycin sulfate; polymyxin b sulfate profile page.
Pharmacology for NDA: 064047
Suppliers and Packaging for NDA: 064047
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 064047 ANDA Bausch & Lomb Incorporated 24208-790 24208-790-62 1 BOTTLE, DROPPER in 1 CARTON (24208-790-62) / 10 mL in 1 BOTTLE, DROPPER
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN gramicidin; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 064047 ANDA A-S Medication Solutions 50090-0247 50090-0247-0 1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML
Approval Date:Jan 31, 1996TE:ATRLD:No

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