Requests that the FDA determine whether the Reference Listed Drug (RLD) SPORANOX (ITRACONAZOLE) Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons.

Documents

Comments

Key Dates

Comment Period OpensApr 13, 2026

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Strides Pharma, Inc.	Apr 13, 2026	--

CDER

Citizen Petition

Strides Pharma Inc

determine whether the

Reference Listed Drug SPORANOX

ITRACONAZOLE

Oral Solution 10mg mL

under New Drug Application N020657

held by JANSSEN PHARMACEUTICALS INC