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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 050065


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NDA 050065 describes MAXITROL, which is a drug marketed by Sandoz and Harrow Eye and is included in three NDAs. It is available from nine suppliers. Additional details are available on the MAXITROL profile page.

The generic ingredient in MAXITROL is dexamethasone; neomycin sulfate; polymyxin b sulfate. There are thirty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050065
Tradename:MAXITROL
Applicant:Sandoz
Ingredient:dexamethasone; neomycin sulfate; polymyxin b sulfate
Patents:0
Pharmacology for NDA: 050065
Suppliers and Packaging for NDA: 050065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065 NDA Novartis Pharmaceuticals Corporation 0078-0771 0078-0771-01 3.5 g in 1 TUBE (0078-0771-01)
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050065 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-4435 50090-4435-0 3.5 g in 1 TUBE (50090-4435-0)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrength0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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