ROSUVASTATIN CALCIUM | A079145 | APOTEX INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petiton from AstraZeneca Pharmaceuticals LP FDA-2016-P-1485 · 6 docket documents AstraZeneca Pharmaceuticals LP filed this citizen petition pursuant to 21 U.S.C. section 355(q) requesting that the FDA Commissioner not approve any ANDA or section 505(b)(2) NDA referencing Crestor (rosuvastatin calcium) until expiration of orphan drug exclusivity for the pediatric treatment of hom | 505(q) Stay Request | 2016-06-06 | Denied | — |
AstraZeneca Pharmaceuticals LP (Covington & Burling LLP) - Citizen Petition FDA-2011-P-0823 · 3 docket documents AstraZeneca Pharmaceuticals LP filed this citizen petition on November 14, 2011, requesting that the FDA not approve any rosuvastatin calcium abbreviated new drug applications (ANDAs) for which Crestor is the reference listed drug if the proposed labeling omits diabetes-related warning and adverse r | 505(q) | 2012-01-24 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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