Details for New Drug Application (NDA): 050065
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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
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | Yes |
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