TACROLIMUS | A065461 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals (Cephalon, Inc) FDA-2015-P-1431 Teva Pharmaceuticals submitted this citizen petition under section 355(q) on behalf of its subsidiary Cephalon, requesting that FDA not approve any abbreviated new drug application for bendamustine (Treanda) referencing the chronic lymphocytic leukemia indication until expiration of the drug's orpha | 505(q) Stay Request | 2015-04-30 | Denied | Teva Pharmaceuticals (Cephalon |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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