| D-0018-2026 | Class II | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count ( | September 19, 2025 |
| D-0020-2026 | Class II | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC | September 19, 2025 |
| D-0019-2026 | Class II | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (ND | September 19, 2025 |
| D-0017-2026 | Class II | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-coun | September 19, 2025 |
| D-0645-2025 | Class II | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd | August 28, 2025 |
| D-0576-2025 | Class II | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: | July 21, 2025 |
| D-0534-2025 | Class II | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alke | July 9, 2025 |
| D-0533-2025 | Class II | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem | July 9, 2025 |
| D-0468-2025 | Class II | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: | May 23, 2025 |
| D-0469-2025 | Class II | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: | May 23, 2025 |
| D-0130-2025 | Class II | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories | December 12, 2024 |
| D-0129-2025 | Class II | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories | December 12, 2024 |
| D-0668-2024 | Class II | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured | September 3, 2024 |
| D-0339-2024 | Class II | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-do | January 16, 2024 |
| D-0237-2024 | Class II | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alke | December 29, 2023 |
| D-1145-2023 | Class III | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured b | July 18, 2023 |
| D-0925-2023 | Class II | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., IND | July 11, 2023 |
| D-0539-2023 | Class II | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Labo | March 17, 2023 |
| D-0533-2023 | Class II | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Labora | March 14, 2023 |
| D-0534-2023 | Class II | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alke | March 14, 2023 |