Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.
QUETIAPINE FUMARATE | N022172 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP - Citizen Petition FDA-2011-P-0663 · 3 docket documents AstraZeneca Pharmaceuticals LP filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any quetiapine abbreviated new drug application (ANDA) with Seroquel XR as the reference listed drug if the proposed labeling omits informat | 505(q) | 2011-09-20 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.