AZITHROMYCIN | N050670 | PFIZER CHEMICALS DIV PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer Inc. FDA-2006-P-0448 Pfizer Inc. submitted this petition on October 4, 2006, requesting that the FDA initiate a recall of Pliva Inc.'s generic azithromycin for oral suspension product due to misbranding regarding the polymorphic form of the active ingredient, which Pfizer's testing showed to be sesquihydrate (Form G) ra | 505(q) | 2008-07-10 | Denied | Pfizer Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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