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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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Table 1--ANDAs for Which Approval Is Withdrawn ------------------------------------------------------------------------ Application No. Drug Applicant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

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