Amneal Pharmaceuticals LLC

FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amnea

August 18, 2025 Amneal Pharmaceuticals LLC 14,923 100-count bottles units

FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 13,130 100-count bottles units

FDA Drug Class II Ongoing

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 60,072 100-count, 73,054 500-count bottles units

FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 7,228 100-count bottles units

FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 3,363 100-count bottles units

FDA Drug Class I Ongoing

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceutica

June 2, 2025 Amneal Pharmaceuticals LLC 6396 bottles units

FDA Drug Class I Ongoing

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewate

April 17, 2025 Amneal Pharmaceuticals LLC 62 (12x100mL) bags units

FDA Drug Class III Completed

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

August 1, 2024 Amneal Pharmaceuticals LLC 12,624 bottles units

FDA Drug Class II Terminated

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

August 31, 2017 Amneal Pharmaceuticals LLC 14,000 vials units

FDA Drug Class II Terminated

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad

December 12, 2016 Amneal Pharmaceuticals LLC 105,215 Bottles units