The FDA's drug database shows a supplement dated 25 September 2026 to a generic ketoconazole application (ANDA 091550, held by Padagis Israel). The record names the product and the applicant only. It does not say what the supplement changed, whether it concerns labelling, manufacturing or something else, or whether it relates to safety.

Supplements to abbreviated applications are routine and most concern manufacturing or labelling housekeeping. Without the supplement text, nothing in this entry changes how ketoconazole should be used. Oral ketoconazole already carries serious warnings in many jurisdictions, including liver toxicity and drug interactions, and decisions about it should follow the current product information.

The record is US-specific. The status of this product in India, including CDSCO action, is not stated in the entry and is unknown from this source.

Check the current product information before prescribing oral ketoconazole, particularly for liver and interaction warnings.
Do not read this entry as a new safety warning; it does not say that.
Monitor liver tests where oral azoles are used for longer courses.
Check interactions before adding any azole antifungal to a patient's regimen.

Why it matters

It is a reminder that a regulatory entry is not the same as a safety alert; the content of the change matters.

Don't overread it

A supplement to a generic application is administrative unless the text says otherwise; the record gives no detail and is not a new indication or warning.