Details for New Drug Application (NDA): 210457
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The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-seven 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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