LANSOPRAZOLE | N021566 | TAKEDA PHARMACEUTICALS NORTH AMERICA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Rose Zhao, Emprise Pharma FDA-2016-P-1037 · 4 docket documents Rose Zhao of Emprise Pharma submitted this petition under 21 CFR 10.30 on March 18, 2016, requesting that the FDA determine that Prevacid IV (lansoprazole IV) 30 mg/vial, approved under NDA 021566, was not discontinued for safety or efficacy reasons, to permit the petitioner to use the discontinued | 505(q) | 2016-03-24 | Granted | Rose Zhao, Emprise Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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