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Details for New Drug Application (NDA): 064053

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NDA 064053 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Luitpold, Alcon Pharms Ltd, and Bausch And Lomb, and is included in six NDAs. It is available from fifteen 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 fifty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.

Summary for NDA: 064053

Pharmacology for NDA: 064053

Suppliers and Packaging for NDA: 064053

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
SOLUTION/DROPS;OTIC 064053 ANDA Major Pharmaceuticals 0904-3141 0904-3141-10 1 BOTTLE, DROPPER in 1 CARTON (0904-3141-10) > 10 mL in 1 BOTTLE, DROPPER
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
hydrocortisone; neomycin sulfate; polymyxin b sulfate
SOLUTION/DROPS;OTIC 064053 ANDA Blenheim Pharmacal, Inc 10544-912 10544-912-99 1 BOTTLE, DROPPER in 1 CARTON (10544-912-99) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrength1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
Approval Date:Dec 29, 1995TE:ATRLD:No


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