Details for New Drug Application (NDA): 220938
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NDA 220938 describes NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, which is a drug marketed by Amneal, Bausch And Lomb Inc, Orbicular Pharm Tech, Sandoz, Saptalis Pharms, and Sciegen Pharms, and is included in nine NDAs. It is available from fourteen 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 is one drug master file entry for this compound. Seventeen 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 is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 220938
| Tradename: | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE |
| Applicant: | Orbicular Pharm Tech |
| Ingredient: | hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 220938
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 220938
| 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 | SOLUTION/DROPS;OTIC | 220938 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0975 | 0054-0975-80 | 1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPER |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SOLUTION/DROPS;OTIC | 220938 | ANDA | Orbicular Pharmaceutical Technologies Private Limited | 81607-014 | 81607-014-10 | 1 BOTTLE, DROPPER in 1 CARTON (81607-014-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | ||||
| Approval Date: | Aug 27, 2026 | TE: | AT | RLD: | No | ||||
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