Details for New Drug Application (NDA): 218559
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NDA 218559 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Padagis Us, Teva, Cosette, Novitium Pharma, Zydus Lifesciences, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in twenty NDAs. It is available from twenty-nine 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 218559
| Tradename: | KETOCONAZOLE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | ketoconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOCONAZOLE | ketoconazole | SHAMPOO;TOPICAL | 218559 | ANDA | Zydus Lifesciences Limited | 70771-1874 | 70771-1874-7 | 120 mL in 1 BOTTLE (70771-1874-7) |
| KETOCONAZOLE | ketoconazole | SHAMPOO;TOPICAL | 218559 | ANDA | Viona Pharmaceuticals Inc | 72578-156 | 72578-156-12 | 120 mL in 1 BOTTLE (72578-156-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SHAMPOO;TOPICAL | Strength | 2% | ||||
| Approval Date: | Mar 7, 2025 | TE: | AB | RLD: | No | ||||
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