QUETIAPINE FUMARATE | N022047 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA PHARMACEUTICALS LP et al v. AMNEAL PHARMACEUTICALS, LLC et al 1 patentANDA 204112quetiapine fumarate | D.N.J. | 2012-08-02 | Terminated 2013-01-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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 | — |
Lachman Consultant Services, Inc - Citizen Petition FDA-2007-P-0011 Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether AstraZeneca Pharmaceuticals LP voluntarily withdrew Seroquel (quetiapine fumarate) 150 mg tablets, approved under NDA 20-639, for safety or effectiveness reasons, or whether the discontinuation wa | 505(q) | 2008-04-10 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$26.36
per ea
Lowest NADAC/Unit
$26.36
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 61269027460SEROQUEL XR 400 MG TABLET | $26.36 | EA | Brand | $0.3172 | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.