ZOLPIDEM TARTRATE | N021412 | BIOVAIL LABORATORIES INTERNATIONAL SRL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from LGM Pharma Solutions, LLC FDA-2026-P-1636 LGM Pharma Solutions, LLC filed this citizen petition requesting that the FDA determine whether Tovalt ODT (Zolpidem Tartrate) 5mg and 10mg tablets, approved under NDA 021412, was voluntarily withdrawn from sale for safety or efficacy reasons. The petitioner seeks this determination under 21 C.F.R. | 505(q) | 2026-02-13 | Open | LGM Pharma Solutions |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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