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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 050023


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NDA 050023 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. Sixteen suppliers are listed for this compound. Additional details are available on the dexamethasone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050023
Pharmacology for NDA: 050023
Suppliers and Packaging for NDA: 050023
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050023 NDA Novartis Pharmaceuticals Corporation 0078-0792 0078-0792-05 5 mL in 1 BOTTLE, PLASTIC (0078-0792-05)
MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050023 NDA Harrow Eye, LLC 82667-100 82667-100-05 5 mL in 1 BOTTLE, PLASTIC (82667-100-05)

Profile for product number 002

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

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