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Details for New Drug Application (NDA): 021738
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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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