Federal Register · Regulatory notice
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Follow ABBV- Became public
- Jun 3, 2026
- Event / period date
- Not stated
- Collected
- Nov 8, 2026, 7:46 PM EST
Why this is connected
The source explicitly mentions AbbVie Inc.. A mention alone does not establish a financial benefit.
Source evidence
Read the source excerpt or record
tunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling. Table 1--ANDAs for Which Approval Is Withdrawn ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 040227............... Phentermine Elite Laboratories, hydrochloride (HCl) Inc., 165/144/135 capsule, 30 Ludlow Ave., milligrams (mg). Northvale, NJ 07647. ANDA 040460............... Phentermine HCl Do. capsule, 15 mg. ANDA 065025............... Cyclosporine AbbVie Inc., 1 N solution, 100 mg/ Waukegan Rd., North milliliters (mL). Chicago, IL 60064. ANDA 075180............... Ranitidine HCl Par Health USA LLC, tablet, Equivalent U.S. Agent for PH to (EQ) 150 mg and Health Limited, 300 EQ 300 mg. Tice Blvd., Suite 230, Woodcliff Lake, NJ 07677. ANDA 076434............... PAROEX (chlorhexidine Sunstar Americas, gluconate) solution, Inc., 301 E Central 0.12%. Rd., Schaumburg, IL 60195. ANDA 090734............... OXYCODONE AND Par Health USA LLC, ACETAMINOPHEN U.S. Agent for PH (acetaminophen; Health Limited, 9 oxycodone HCl) Great Valley tablet, 325 mg; 7.5 Parkway, Malvern, PA mg and 325 mg; 10 mg. 19355. ANDA 204960............... Cisatracurium eVenus Pharmaceutical besylate injectable, Lab Inc., U.S. Agent EQ 2
Congressional trading in ABBV
These disclosures provide context. Their presence does not establish a link between a trader and the event.
- Oct 7, 2026$15K–$50K
Rep. Ro Khanna (D-CA-17)
$15K–$50K · Traded Sep 4, 2026 · disclosed Oct 7, 2026 · Spouse
- Sep 18, 2026$15K–$50K
Rep. Pete Sessions (R-TX-17)
$15K–$50K · Traded Sep 14, 2026 · disclosed Sep 18, 2026
- Jul 21, 2026$15K–$50K
Sen. Alan Armstrong (R-OK)
$15K–$50K · Traded Mar 27, 2026 · disclosed Jul 21, 2026 · filed 116 days later
Committee overlap: HELP - Jun 3, 2026$1K–$15K
Rep. Josh Gottheimer (D-NJ-5)
$1K–$15K · Traded May 5, 2026 · disclosed Jun 3, 2026 · Joint
- Feb 6, 2026$15K–$50K
Rep. Ro Khanna (D-CA-17)
$15K–$50K · Traded Jan 29, 2026 · disclosed Feb 6, 2026 · Spouse
- Jan 15, 2026$1K–$15K
Rep. Julie Johnson (D-TX-32)
$1K–$15K · Traded Dec 18, 2025 · disclosed Jan 15, 2026 · Joint
- Jan 13, 2026$1K–$15K
- Jan 13, 2026$1K–$15K
Rep. Julia Letlow (R-LA-5)
$1K–$15K · Traded Apr 28, 2025 · disclosed Jan 13, 2026 · filed 260 days later
Original documents control. Public records can be amended, and company connections may require interpretation. Nothing here is investment advice.