Details for New Drug Application (NDA): 062341
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NDA 062341 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.
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 062341
| Tradename: | MAXITROL |
| Applicant: | Sandoz |
| Ingredient: | dexamethasone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 062341
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 062341
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAXITROL | dexamethasone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OPHTHALMIC | 062341 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9511 | 53002-9511-1 | 5 mL in 1 BOTTLE, DROPPER (53002-9511-1) |
| MAXITROL | dexamethasone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OPHTHALMIC | 062341 | ANDA | Sandoz Inc. | 61314-630 | 61314-630-06 | 5 mL in 1 BOTTLE, PLASTIC (61314-630-06) |
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: | May 22, 1984 | TE: | AT | RLD: | No | ||||
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