Details for New Drug Application (NDA): 210457
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NDA 210457 describes KETOCONAZOLE, which is a drug marketed by Padagis Israel, Xiromed, Encube, Fougera Pharms, Teva, Trupharma, 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 nineteen NDAs. It is available from twenty-seven 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 210457
| Tradename: | KETOCONAZOLE |
| Applicant: | Strides Pharma |
| Ingredient: | ketoconazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KETOCONAZOLE | ketoconazole | TABLET;ORAL | 210457 | ANDA | Strides Pharma Science Limited | 64380-827 | 64380-827-06 | 100 TABLET in 1 BOTTLE (64380-827-06) |
| KETOCONAZOLE | ketoconazole | TABLET;ORAL | 210457 | ANDA | Strides Pharma Science Limited | 64380-827 | 64380-827-07 | 500 TABLET in 1 BOTTLE (64380-827-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 18, 2018 | TE: | AB | RLD: | No | ||||
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