Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record. See the AbbVie group view.
As of Nov 13, 2026, FDA's public records list AbbVie and its 22 subsidiaries with 370 drug applications, 103 510(k) clearances, 51 drug recalls, 36 device recalls, 4 OPDP letters, 3 complete response letters and 1 warning letter. The most recent is a complete response letter dated Apr 22, 2026: Complete response letter, BLA 761459.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, AbbVie and its 22 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 22, 2026 | Complete response letter, BLA 761459Unapproved | Complete response letters |
| Jan 16, 2026 | Natrelle 133S Tissue ExpandersK254126 · LCJ | 510(k) clearances |
| Sep 9, 2025 | Untitled letter: SKYRIZIOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Untitled letter: QuliptaOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Untitled letter: LINZESSOffice of Prescription Drug Promotion | OPDP letters |
| Sep 12, 2024 | CoolSculpting Elite SystemK233732 · OOK | 510(k) clearances |
| Aug 29, 2024 | Untitled letter: UBRELVYOffice of Prescription Drug Promotion | OPDP letters |
| Jun 18, 2024 | Complete response letter, NDA 216962Approved | Complete response letters |
| Feb 1, 2024 | Resonic Rapid Acoustic Pulse DeviceK233804 · GEX | 510(k) clearances |
| Mar 17, 2023 | Complete response letter, NDA 216962Approved | Complete response letters |
| Sep 25, 2022 | Resonic Rapid Acoustic Pulse DeviceK222629 · GEX | 510(k) clearances |
| Nov 5, 2021 | Resonic Rapid Acoustic Pulse DeviceK212502 · GEX | 510(k) clearances |
| Nov 5, 2021 | CoolSculpting Elite SystemK212707 · OOK | 510(k) clearances |
| Jun 2, 2021 | NATRELLE INSPIRA Single Use Sizers for Gel ImplantsK203229 · MRD | 510(k) clearances |
| Apr 27, 2021 | Resonic Rapid Acoustic Pulse DeviceK210964 · GEX | 510(k) clearances |
| May 14, 2020 | Warning letter: 510(k) requiredCDRH | Warning letters |
| Aug 8, 2017 | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body conClass II · Presence of bacterial endotoxins levels above the acceptable limit | Device recalls |
| May 18, 2017 | Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Class II · Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
