Details for New Drug Application (NDA): 065108
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NDA 065108 describes NEOMYCIN AND POLYMYXIN B SULFATE, which is a drug marketed by Watson Labs, Xgen Pharms, Bausch And Lomb, Padagis Us, Sciegen Pharms Inc, Alcon Pharms Ltd, Ipharm, Nordic Pharma, Amring Pharms, and Sandoz, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATE profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATE is bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATE is bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 065108
| Tradename: | NEOMYCIN AND POLYMYXIN B SULFATE |
| Applicant: | Xgen Pharms |
| Ingredient: | neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065108
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATE | neomycin sulfate; polymyxin b sulfate | SOLUTION;IRRIGATION | 065108 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-1220 | 39822-1220-1 | 1 VIAL, GLASS in 1 CARTON (39822-1220-1) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | EQ 40MG BASE/ML;200,000 UNITS/ML | ||||
| Approval Date: | Jan 31, 2006 | TE: | AT | RLD: | No | ||||
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