Details for New Drug Application (NDA): 062938
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NDA 062938 describes NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, which is a drug marketed by Bausch And Lomb, Padagis Us, and Alcon Pharms Ltd, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE 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.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE 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 062938
| Tradename: | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE |
| Applicant: | Padagis Us |
| Ingredient: | dexamethasone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 062938
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 062938
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | dexamethasone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 062938 | ANDA | Padagis US LLC | 0574-4160 | 0574-4160-35 | 1 TUBE in 1 CARTON (0574-4160-35) / 3.5 g in 1 TUBE |
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | dexamethasone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 062938 | ANDA | Proficient Rx LP | 63187-395 | 63187-395-35 | 1 TUBE in 1 CARTON (63187-395-35) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | ||||
| Approval Date: | Jul 31, 1989 | TE: | AT | RLD: | No | ||||
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