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 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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