Details for New Drug Application (NDA): 064068
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NDA 064068 describes NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, which is a drug marketed by Bausch And Lomb and Sciegen Pharms Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE profile page.
The generic ingredient in NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 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 SULFATES, BACITRACIN ZINC AND HYDROCORTISONE 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 064068
| Tradename: | NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE |
| Applicant: | Bausch And Lomb |
| Ingredient: | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 064068
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
| Physiological Effect | Decreased Cell Wall Synthesis & Repair |
Suppliers and Packaging for NDA: 064068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 064068 | ANDA | Bausch & Lomb Incorporated | 24208-785 | 24208-785-55 | 1 TUBE in 1 CARTON (24208-785-55) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | ||||
| Approval Date: | Oct 30, 1995 | TE: | RLD: | No | |||||
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