Details for New Drug Application (NDA): 213601
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NDA 213601 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Teva, Trupharma, Cosette, Novitium Pharma, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in eighteen NDAs. It is available from twenty-five suppliers. Additional details are available on the KETOCONAZOLE profile page.
The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 213601
| Tradename: | KETOCONAZOLE |
| Applicant: | Xiromed |
| Ingredient: | ketoconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213601
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOCONAZOLE | ketoconazole | AEROSOL, FOAM;TOPICAL | 213601 | ANDA | Xiromed, LLC | 70700-160 | 70700-160-19 | 50 g in 1 CAN (70700-160-19) |
| KETOCONAZOLE | ketoconazole | AEROSOL, FOAM;TOPICAL | 213601 | ANDA | Xiromed, LLC | 70700-160 | 70700-160-20 | 100 g in 1 CAN (70700-160-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 2% | ||||
| Approval Date: | May 21, 2021 | TE: | AB | RLD: | No | ||||
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