Granules Pharmaceuticals Inc

FDA Drug Class II Ongoing

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151

January 26, 2026 Granules Pharmaceuticals Inc 71424 bottles. units

FDA Drug Class III Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20

August 28, 2025 Granules Pharmaceuticals Inc 11,909 bottles units

FDA Drug Class III Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 m

August 28, 2025 Granules Pharmaceuticals Inc 3,384 bottles units

FDA Drug Class III Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10

August 28, 2025 Granules Pharmaceuticals Inc 11,895 bottles units

FDA Drug Class III Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15

August 28, 2025 Granules Pharmaceuticals Inc 9,917 bottles units

FDA Drug Class III Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30

August 28, 2025 Granules Pharmaceuticals Inc 11,928 bottles units

FDA Drug Class II Ongoing

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, H

June 24, 2025 Granules Pharmaceuticals Inc 27,648 100-count Bottles; 5,376 500-count Bottles units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutica

December 30, 2024 Granules Pharmaceuticals Inc 6,804 bottles units

FDA Drug Class II Terminated

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

December 18, 2024 Granules Pharmaceuticals Inc 96 Bottles units

FDA Drug Class II Terminated

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-

July 31, 2024 Granules Pharmaceuticals Inc 11,808 500-count Bottles units

FDA Drug Class II Ongoing

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA,

July 3, 2020 Granules Pharmaceuticals Inc a) 476,073 bottles; b) 2,100 bottles units