PROMETHAZINE HYDROCHLORIDE | N008857 | WYETH AYERST LABORATORIES
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Taro Pharmaceuticals USA, Inc. FDA-2006-P-0005 Taro Pharmaceuticals USA, Inc. filed this citizen petition on October 31, 2006, requesting that the FDA make a determination of ANDA suitability for Promethazine Hydrochloride Suppositories USP in 12.5 mg and 25 mg strengths, which were voluntarily withdrawn from sale by Wyeth for reasons other than | Other | 2008-08-12 | Open | Taro Pharmaceuticals USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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