Details for New Drug Application (NDA): 062488
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NDA 062488 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amring Pharms, Bausch And Lomb, and Sandoz, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 062488
| Tradename: | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| Applicant: | Sandoz |
| Ingredient: | hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 062488
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 062488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 062488 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9001 | 53002-9001-1 | 10 mL in 1 BOTTLE, PLASTIC (53002-9001-1) |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 062488 | ANDA | Sandoz Inc. | 61314-645 | 61314-645-11 | 10 mL in 1 BOTTLE, PLASTIC (61314-645-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ||||
| Approval Date: | Nov 6, 1985 | TE: | AT | RLD: | No | ||||
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