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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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 LLY
Became public
Jul 6, 2026
Event / period date
Not stated
Collected
Nov 8, 2026, 7:38 PM EST

Why this is connected

The source explicitly mentions ELI LILLY & Co. A mention alone does not establish a financial benefit.

Source evidence

Read the source excerpt or record
ayed-Release Way, Deerfield, IL Tablets, EQ 20 mg 60015. base; 375 mg, and EQ 20 mg base; 500 mg. NDA 050467.............. Doxorubicin Pfizer Inc., 66 Hudson Hydrochloride Blvd. East, New York, (doxorubicin HCl) NY 10001. Injectable, 10 mg/ vial, 20 mg/vial, 50 mg/vial, and 150 mg/ vial. NDA 201194.............. Oxycodone VistaPharm, LLC, 20 Hydrocholoride Waterview Blvd., (oxycodone HCl) Suite 303, Solution, 5 mg/5 mL. Parsippany, NJ 07054. NDA 202020.............. Rayos (prednisone) Horizon Therapeutics Delayed-Release USA, Inc., 1 Horizon Tablets, 1 mg, 2 mg, Way, Deerfield, IL and 5 mg. 60015. NDA 204623.............. Pennsaid (diclofenac Horizon Therapeutics sodium) Solution, 2%. Ireland DAC c/o Horizon Therapeutics USA, Inc., 1 Horizon Way, Deerfield, IL 60015. NDA 204803.............. Posimir (bupivacaine) Innocoll Solution, 660 mg/5 mL Pharmaceuticals (132 mg/mL). Limited c/o Allucent, 2000 Centregreen Way, Suite 300, Cary, NC 27513. NDA 206030.............. Carnexiv Lundbeck (carbamazepine) Pharmaceuticals LLC, Solution, 200 mg/20 6 Pkwy. North, Suite mL (10 mg/mL). 400, Deerfield, IL 60015. NDA 209128.............. Dsuvia (sufentanil Vertical citrate) Tablet, EQ Pharmaceuticals, LLC, 0.03 mg base. 1880 McFarland Pkwy., Suite 110B, Alpharetta, GA 30005. NDA 209511.............. Xaracoll (bupivacaine Innocoll HCl) Implant, 100 mg. Pharmaceuticals Limited c/o Allucent, 2

Congressional trading in LLY

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Original documents control. Public records can be amended, and company connections may require interpretation. Nothing here is investment advice.