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Details for New Drug Application (NDA): 021738
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NDA 021738 describes EXTINA, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. 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. Twenty-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. Twenty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 021738
| Tradename: | EXTINA |
| Applicant: | Mylan |
| Ingredient: | ketoconazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
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 AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-7007 | 0378-7007-01 | 1 CAN in 1 CARTON (0378-7007-01) > 100 g in 1 CAN |
| EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-7007 | 0378-7007-50 | 1 CAN in 1 CARTON (0378-7007-50) > 50 g in 1 CAN |
Paragraph IV (Patent) Challenges for 021738
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXTINA | AEROSOL, FOAM;TOPICAL | ketoconazole | 021738 | 2009-07-30 |
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 | ||||
Expired US Patents for NDA 021738
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | Start Trial | Start Trial |
| Mylan | EXTINA | ketoconazole | AEROSOL, FOAM;TOPICAL | 021738-001 | Jun 12, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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