Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
QUETIAPINE FUMARATE | N022172 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP - Citizen Petition FDA-2011-P-0663 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.