NYSTATIN | A062613 | PADDOCK LABORATORIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Paddock Laboratories, Inc. - Citizen Petition FDA-2010-P-0201 · 8 docket documents Paddock Laboratories, Inc. filed this citizen petition under 21 CFR 314.161 requesting that the FDA determine whether Nilstat (Nystatin Powder; Oral 100%), previously approved through NDA 050576, was withdrawn from the market for safety or effectiveness reasons. The petitioner seeks this determinati | 505(q) | 2010-04-26 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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