Details for New Drug Application (NDA): 050218
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NDA 050218 describes CORTISPORIN, which is a drug marketed by Monarch Pharms and Casper Pharma Llc and is included in five NDAs. Additional details are available on the CORTISPORIN profile page.
The generic ingredient in CORTISPORIN 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 CORTISPORIN 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 050218
| Tradename: | CORTISPORIN |
| Applicant: | Monarch Pharms |
| Ingredient: | hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 9, 1985 | TE: | RLD: | Yes | |||||
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