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NDC 64380-0827-06

KETOCONAZOLE 200 mg/1 TABLET

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NDC
64380-0827-06
Generic Name
KETOCONAZOLE
Brand Name
KETOCONAZOLE
Strength
200 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
—
Labeler
Strides Pharma Science Limited

FDA Drug Information

Indications & Usage

INDICATIONS & USAGE Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies…

Important Warnings

WARNINGS Because of the serious adverse reactions that have been reported in association with ketoconazole, including fatal hepatotoxicity, ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential be…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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