Details for New Drug Application (NDA): 064135
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The generic ingredient in DEXASPORIN 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 064135
Tradename: | DEXASPORIN |
Applicant: | Bausch And Lomb |
Ingredient: | dexamethasone; neomycin sulfate; polymyxin b sulfate |
Patents: | 0 |
Pharmacology for NDA: 064135
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 064135
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXASPORIN | dexamethasone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OPHTHALMIC | 064135 | ANDA | Bausch & Lomb Incorporated | 24208-830 | 24208-830-60 | 1 BOTTLE, DROPPER in 1 CARTON (24208-830-60) / 5 mL in 1 BOTTLE, DROPPER |
DEXASPORIN | dexamethasone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OPHTHALMIC | 064135 | ANDA | medsource pharmaceuticals | 45865-796 | 45865-796-01 | 1 BOTTLE, DROPPER in 1 CARTON (45865-796-01) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ||||
Approval Date: | Sep 13, 1995 | TE: | AT | RLD: | No |
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