THEOPHYLLINE | A085328 | SCHERING CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc. FDA-2021-P-1154 · 6 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether THEO-DUR (theophylline) extended release tablets 300mg, NDA Number N085328, held by Schering, was voluntarily withdrawn from the commercial market for reasons of safety or efficacy. The petitioner | 505(q) | 2021-10-27 | Granted | Lachman Consultant Services Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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