SOMERSET THERAPEUTICS LLC

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL

November 26, 2025 SOMERSET THERAPEUTICS LLC 71,310 10mL vials units

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-do

November 26, 2025 SOMERSET THERAPEUTICS LLC 52,340 5mL vials units

FDA Drug Class III Ongoing

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single d

November 26, 2025 SOMERSET THERAPEUTICS LLC 28,660 20mL vials units

FDA Drug Class III Terminated

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

December 16, 2024 SOMERSET THERAPEUTICS LLC 5,870 bottles units

FDA Drug Class II Ongoing

Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,

April 24, 2024 SOMERSET THERAPEUTICS LLC 5,578 units units

FDA Drug Class III Terminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01

June 4, 2020 SOMERSET THERAPEUTICS LLC 383,437 bottles units

FDA Drug Class III Terminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01

June 4, 2020 SOMERSET THERAPEUTICS LLC 22,788 bottles units

FDA Drug Class III Terminated

Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01

June 4, 2020 SOMERSET THERAPEUTICS LLC 48,852 bottles units