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Generated: May 27, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Antifungals |
| Formulation / Manufacturing: | see details |
| Ingredient-type | Azoles |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
EXTINA |
ketoconazole |
AEROSOL, FOAM;TOPICAL | 021738 | NDA | Prestium Pharma, Inc. | 40076-051 | 40076-051-00 | 100 g in 1 CAN (40076-051-00) |
EXTINA |
ketoconazole |
AEROSOL, FOAM;TOPICAL | 021738 | NDA | Prestium Pharma, Inc. | 40076-051 | 40076-051-50 | 50 g in 1 CAN (40076-051-50) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jun 12, 2007 | TE: | AT | RLD: | Yes | ||||
| Patent: | 8,026,238 | Patent Expiration: | Oct 19, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 7,553,835 | Patent Expiration: | Oct 19, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS | ||||||||
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