PACLITAXEL | N020262 | HQ SPECIALTY PHARMA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alembic Pharmaceutical Limited FDA-2021-P-1215 Alembic Pharmaceutical Limited filed this citizen petition requesting that the FDA determine whether TAXOL (paclitaxel injection, USP) 6 mg/mL, approved under NDA 020262 by HQ Specialty Pharma Corp, was withdrawn for reasons related to safety or effectiveness. The petitioner seeks a determination th | 505(q) | 2021-11-12 | Open | Alembic Pharmaceutical Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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