INDOMETHACIN | A216184 | ZYDUS LIFESCIENCES GLOBAL FZE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Wiley Rein LLP FDA-2025-P-5921 · 47 docket documents Wiley Rein LLP filed this citizen petition on behalf of a client opposing Wells Pharma's compounded Indomethacin 100 mg Rectal Suppository, requesting immediate withdrawal of the product, cessation of manufacturing until Wells Pharma obtains FDA approval via a New Drug Application with full pharmace | Other | 2025-11-07 | Open | Wiley Rein LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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