THEOPHYLLINE | A087449 | ROXANE LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Silarx Pharmaceuticals, Inc - Citizen Petition FDA-2009-P-0257 · 6 docket documents Silarx Pharmaceuticals, Inc. filed this citizen petition on May 29, 2009, requesting that the FDA Commissioner allow the company to proceed with ANDA number 091156 for Theophylline Oral Solution despite the absence of an approved referenced listed drug in the Orange Book, after the original RLD prod | 505(q) | 2009-06-11 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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