Details for New Drug Application (NDA): 064065
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NDA 064065 describes OTICAIR, which is a drug marketed by Bausch And Lomb and Pharmafair and is included in two NDAs. It is available from seven suppliers. Additional details are available on the OTICAIR profile page.
The generic ingredient in OTICAIR 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 OTICAIR 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 064065
| Tradename: | OTICAIR |
| Applicant: | Bausch And Lomb |
| Ingredient: | hydrocortisone; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Pharmacology for NDA: 064065
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 064065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OTICAIR | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 064065 | ANDA | Bausch & Lomb Incorporated | 24208-635 | 24208-635-62 | 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) / 10 mL in 1 BOTTLE, DROPPER |
| OTICAIR | hydrocortisone; neomycin sulfate; polymyxin b sulfate | SUSPENSION/DROPS;OTIC | 064065 | ANDA | RPK Pharmaceuticals, Inc. | 53002-9000 | 53002-9000-1 | 1 BOTTLE, DROPPER in 1 CARTON (53002-9000-1) / 10 mL in 1 BOTTLE, DROPPER |
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: | Aug 28, 1996 | TE: | AT | RLD: | No | ||||
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