ITRACONAZOLE | N020657 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Strides Pharma, Inc. FDA-2026-P-4021 Strides Pharma, Inc. filed a citizen petition under Section 505(j) requesting that the FDA determine whether SPORANOX (itraconazole) Oral Solution 10 mg/mL, NDA N020657 held by Janssen Pharmaceuticals Inc., was withdrawn for safety or efficacy reasons or for commercial reasons only. Strides seeks co | Other | 2026-04-13 | Open | Strides Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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