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Federal Register · Regulatory notice

Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
Jul 6, 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
ution, 10 mg/ml. Inc., 1125 Trenton- Harbourton Rd., Titusville, NJ 08560. NDA 021040.............. Prefest (estradiol 1mg Teva Women's Health, and estradiol; Inc., 145 Brandywine norgestimate 1 mg; Pkwy., West Chester, 0.09 mg), Tablets. PA 19380. NDA 021292.............. Euthyrox EMD Serono, Inc. c/o (levothyroxine ICON Clinical sodium) Tablets, Research LLC, 731 0.025 mg, 0.05 mg, Arbor Way, Suite 100, 0.075 mg, 0.088 mg, Blue Bell, PA 19422. 0.1 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg. NDA 021416.............. Rythmol SR GlaxoSmithKline LLC, (propafenone HCl) 2929 Walnut St., Extended-Release Suite 1700, Capsules, 225 mg, 325 Philadelphia, PA mg, and 425 mg.. 19104. [[Page 41046]] NDA 021481.............. Fuzeon (enfuviritide) Hoffmann-La Roche Inc. Injectable, 90 mg/ c/o Genentech, Inc., vial.. 1 DNA Way, South San Francisco, CA 94080. NDA 021548.............. Lexivia (fosamprenavir Viiv Healthcare Co., calcium) Tablet, EQ 410 Blackwell St., 700 mg base.. Durham, NC 27701. NDA 021606.............. Zemplar (paricalcitol) AbbVie Inc., 1 N Capsules, 1 microgram Waukegan Rd., North (mcg), 2 mcg, and 4 Chicago, IL 60064. mcg. NDA 021656.............. TriCor (fenofibrate) AbbVie Inc., 1 N Tablets, 48 mg and Waukegan Rd., North 145 mg. Chicago, IL 60064. NDA 021779.............. Ventavis (iloprost) Actelion Solution, 10 mcg/mL Pharmaceuticals US, (

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