| These highlights do not include all the information needed to use AZSTARYS safely and effectively. See full prescribing information for AZSTARYS. AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) capsules, for oral use, CII Initial U.S. Approval: 2021 | Commave Sub, LLC | Commave Therapeutics SA | 20260511 | 9 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20260331 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20260331 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20260317 | 101 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20260317 | 101 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Par Health USA, LLC | 20260105 | 22 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Nivagen Pharmaceuticals, Inc. | 20260101 | 2 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | KVK-TECH, INC | ABHAI, LLC | 20251124 | 14 |
| Dexmethylphenidate hydrochloride extended-release capsules These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Granules Pharmaceuticals Inc. | 20251015 | 9 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Amneal Pharmaceuticals of New York LLC | 20251009 | 15 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Amneal Pharmaceuticals of New York LLC | 20251009 | 22 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HCL EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2001 | Lannett Company, Inc. | 20250925 | 10 |
| These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Novartis Pharmaceuticals Corporation | 20250923 | 36 |
| These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Sandoz Inc | 20250923 | 5 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Teva Pharmaceuticals USA, Inc. | 20250430 | 23 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Neolpharma, Inc. | 20241212 | 13 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 103 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 102 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 102 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 102 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 102 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240812 | 102 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240808 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240808 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240808 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240808 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240808 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Cranbury Pharmaceuticals, LLC | 20240731 | 23 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20240716 | 8 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240605 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240530 | 104 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Bryant Ranch Prepack | 20240530 | 104 |
| These highlights do not include all the information needed to use FOCALIN safely and effectively. See full prescribing information for FOCALIN. FOCALIN ® (dexmethylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 2001 | Sandoz Inc | 20240530 | 2 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240201 | 100 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240201 | 100 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240201 | 100 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 2005 | Par Health USA, LLC | 20240131 | 13 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS s afely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS . DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc. | 20240130 | 7 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240110 | 103 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Bryant Ranch Prepack | 20240110 | 103 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 2001 | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 20240102 | 13 |
| These highlights do not include all the information needed to use FOCALIN safely and effectively. See full prescribing information for FOCALIN. FOCALIN ® (dexmethylphenidate hydrochloride) tablets, for oral use, CII Initial U.S. Approval: 2001 | Novartis Pharmaceuticals Corporation | 20231013 | 28 |
| These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 | Camber Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20211217 | 1 |
| These highlights do not include all the information needed to use Dexmethylphenidate hydrochloride tablets safely and effectively. See full prescribing information for Dexmethylphenidate hydrochloride tablets.Dexmethylphenidate hydrochloride tablets, for oral use, CII Initial U.S. Approval: 2001 | Bionpharma Inc. | 20200401 | 1 |
| These highlights do not include all the information needed to use Dexmethylphenidate Hydrochloride Extended-Release Capsules safely and effectively. See full prescribing information for Dexmethylphenidate Hydrochloride Extended-Release Capsules. Dexmethylphenidate Hydrochloride Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005 | Avera McKennan Hospital | 20151223 | 1 |
| These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005 | STAT RX USA LLC | 20110613 | 1 |
| These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005 | Physicians Total Care, Inc. | 20101111 | 2 |