QUETIAPINE FUMARATE | N020639 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-1033 · 8 docket documents Pharmobedient Consulting, LLC submitted a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Quetiapine Tablets 12.5 mg suitable for submission in an Abbreviated New Drug Application, with SEROQUEL | Suitability | 2025-04-03 | Open | Pharmobedient Consulting, LLC |
Covington & Burling LLP (AstraZeneca Pharmaceuticals LP) - Citizen Petition FDA-2011-P-0662 · 3 docket documents AstraZeneca Pharmaceuticals LP, the NDA holder for SEROQUEL (quetiapine fumarate), filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any quetiapine ANDA if the proposed labeling omits information that FDA required AstraZe | 505(q) | 2011-09-20 | DeniedUnverified summary | — |
Lachman Consultant Services, Inc - Citizen Petition FDA-2007-P-0011 · 6 docket documents 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 | GrantedUnverified summary | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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