LEADIANT BIOSCIENCES, INC

FDA Drug Class II Terminated

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 2087

February 3, 2023 LEADIANT BIOSCIENCES, INC 31,879 vials units

FDA Drug Class III Terminated

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc

September 24, 2020 LEADIANT BIOSCIENCES, INC 1380 bottles units

FDA Drug Class III Terminated

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482

April 9, 2018 LEADIANT BIOSCIENCES, INC 3,398 bottles units

FDA Drug Class III Terminated

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 544

February 14, 2018 LEADIANT BIOSCIENCES, INC 1,705 bottles units