| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Par Health USA, LLC | 20260507 | 23 |
| 4dc74ada-f633-3f1a-e063-6394a90a191e | Yunigen, Inc. | 20260406 | 2 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | American Health Packaging | 20260302 | 12 |
| These highlights do not include all the information needed to use XROMI safely and effectively. See full prescribing information for XROMI. XROMI (hydroxyurea) oral solution Initial U.S. Approval: 1967 | Nova Laboratories, Ltd. | Rare Disease Therapeutics, Inc. | Nova Laboratories, Ltd | 20260202 | 10 |
| These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA. DROXIA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967 | H2-Pharma LLC | CHEPLAPHARM Arzneimittel GmbH | 20260126 | 24 |
| These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA. HYDREA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967 | H2-Pharma LLC | CHEPLAPHARM Arzneimittel GmbH | 20260126 | 21 |
| These highlights do not include all the information needed to use SIKLOS safely and effectively. See full prescribing information for SIKLOS. SIKLOS (hydroxyurea) tablets, for oral use Initial U.S. Approval: 1967 | Medunik | Addmedica | 20260107 | 13 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Coupler LLC | Qilu Pharmaceutical Co., Ltd. | 20251202 | 1 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Major Pharmaceuticals | 20251118 | 7 |
| Hydroxyurea Capsules USP Rx Only These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | AvKARE | 20251015 | 10 |
| These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA. HYDREA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967 | Waylis Therapeutics LLC | Latina Pharma SpA | 20250915 | 1 |
| These highlights do not include all the information needed to use DROXIA safely and effectively. See full prescribing information for DROXIA. DROXIA (hydroxyurea) capsules, for oral use Initial U.S. Approval: 1967 | Waylis Therapeutics LLC | Latina Pharma SpA | 20250912 | 1 |
| HYDROXYUREA CAPSULES. These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967. | Golden State Medical Supply, Inc. | 20241125 | 2 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967. | Leading Pharma, LLC | Halo Pharmaceutical Inc | 20241029 | 11 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Somerset Therapeutics, LLC | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) | 20240923 | 2 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Teva Pharmaceuticals USA, Inc. | 20240530 | 20 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use Initial U.S. Approval: 1967 | Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park) | 20240430 | 2 |
| These highlights do not include all the information needed to use HYDROXYUREA CAPSULES safely and effectively. See full prescribing information for HYDROXYUREA CAPSULES. HYDROXYUREA capsules, for oral use. Initial U.S. Approval: 1967. | Marlex Pharmaceuticals, Inc. | 20231108 | 2 |
| HYDROXYUREA CAPSULES USP | Physicians Total Care, Inc. | 20120601 | 2 |