Details for New Drug Application (NDA): 062166
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NDA 062166 describes BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, which is a drug marketed by Altana and Padagis Us and is included in two NDAs. It is available from one supplier. Additional details are available on the BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE profile page.
The generic ingredient in BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE is bacitracin zinc; hydrocortisone acetate; 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 acetate; neomycin sulfate; polymyxin b sulfate profile page.
The generic ingredient in BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE is bacitracin zinc; hydrocortisone acetate; 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 acetate; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 062166
| Tradename: | BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE |
| Applicant: | Padagis Us |
| Ingredient: | bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 062166
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
| Physiological Effect | Decreased Cell Wall Synthesis & Repair |
Suppliers and Packaging for NDA: 062166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 062166 | ANDA | Padagis US LLC | 0574-4144 | 0574-4144-35 | 1 TUBE in 1 CARTON (0574-4144-35) / 3.5 g in 1 TUBE |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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