Details for New Drug Application (NDA): 064135
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NDA 064135 describes DEXASPORIN, which is a drug marketed by Pharmafair and Bausch And Lomb and is included in three NDAs. It is available from eight suppliers. Additional details are available on the DEXASPORIN profile page.
The generic ingredient in DEXASPORIN 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.
The generic ingredient in DEXASPORIN 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 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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