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Details for New Drug Application (NDA): 021738
NDA 021738 describes EXTINA, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EXTINA profile page.
The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 021738
| Tradename: | EXTINA |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | ketoconazole |
| Patents: | 2 |
| Therapeutic Class: | Antifungals |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021738
| Ingredient-type | Azoles |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 021738
Suppliers and Packaging for NDA: 021738
| 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 | N | 40076-051-00 |
| EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738 | NDA | Prestium Pharma, Inc. | 40076-051 | N | 40076-051-50 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | Jun 12, 2007 | TE: | AT | RLD: | Yes | ||||
| Patent: | ➤ Sign Up | Patent Expiration: | Oct 19, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Oct 19, 2018 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETENT PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
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