Novartis Pharmaceuticals Corporation

FDA Drug Class I Ongoing

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corpo

November 22, 2023 Novartis Pharmaceuticals Corporation 6,997 bottles units

FDA Drug Class II Terminated

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 007

September 16, 2022 Novartis Pharmaceuticals Corporation 132,999 cartons units

FDA Drug Class III Terminated

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-

May 10, 2022 Novartis Pharmaceuticals Corporation 279,179 vials units

FDA Drug Class III Terminated

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-

May 10, 2022 Novartis Pharmaceuticals Corporation 279,179 vials units

FDA Drug Class III Terminated

Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 540

May 10, 2022 Novartis Pharmaceuticals Corporation 1,253,862 vials units

FDA Drug Class III Terminated

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-

May 10, 2022 Novartis Pharmaceuticals Corporation 1,187,092 vials units