LABETALOL HYDROCHLORIDE | A075239 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nexsen Pruet LLC FDA-2021-P-0162 · 4 docket documents Nexsen Pruet LLC filed this citizen petition requesting that the FDA determine whether Normodyne (labetalol hydrochloride) Injection USP, 5 mg/mL, NDA No. 018686, was withdrawn from the market for safety or efficacy reasons. The petitioner argues that since the drug was withdrawn for commercial reas | 505(q) | 2021-02-09 | Granted | Nexsen Pruet LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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