| These highlights do not include all the information needed to use linezolid safely and effectively. See full prescribing information for linezolid. LINEZOLID ORAL SUSPENSION Initial U.S. Approval: 2000 | Mylan Pharmaceuticals Inc. | 20260522 | 15 |
| These highlights do not include all the information needed to use linezolid safely and effectively. See full prescribing information for linezolid. LINEZOLID TABLETS, FOR ORAL USE Initial U.S. Approval: 2000 | Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Asia Manufacturing Pte Ltd | 20260522 | 16 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, for intravenous use ZYVOX ® (linezolid) tablets, for oral use ZYVOX ® (linezolid) for oral suspension Initial U.S. Approval: 2000 | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | NEOLPHARMA, INC. | Pfizer Manufacturing Deutschland GmbH | 20260519 | 69 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, for intravenous use Initial U.S. Approval: 2000 | Pharmacia & Upjohn Company LLC | Pfizer Asia Manufacturing Pte Ltd | 20260515 | 23 |
| These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Hospira, Inc. | Pfizer Asia Manufacturing Pte Ltd | 20260513 | 20 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Sportpharm LLC | 20260424 | 2 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Caplin Steriles Limited | 20251223 | 1 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | REMEDYREPACK INC. | 20251212 | 4 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Major Pharmaceuticals | Alkem Laboratories Limited | 20251113 | 4 |
| Linezolid Tablets These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. Linezolid Tablets, for oral use Initial U.S. Approval: 2000 | Chartwell RX, LLC | 20251104 | 3 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Piramal Critical Care Inc. | 20251022 | 8 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Piramal Critical Care Inc | 20250925 | 9 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Coupler LLC | 20250904 | 1 |
| These highlights do not include all the information needed to use LINEZOLID safely and effectively. See full prescribing information for LINEZOLID. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Bryant Ranch Prepack | 20250826 | 103 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Bryant Ranch Prepack | 20250826 | 3 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20250613 | 19 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Hikma Pharmaceuticals USA Inc. | 20250509 | 12 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Sun Pharmaceutical Industries, Inc. | 20250217 | 19 |
| These highlights do not include all the information needed to use LINEZOLID for Oral Suspension safely and effectively. See full prescribing information for LINEZOLID for Oral Suspension. LINEZOLID for oral suspension Initial U.S. Approval: 2000 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20250130 | 16 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V | 20250109 | 5 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | American Health Packaging | 20241122 | 6 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Rising Pharma Holdings, Inc. | APPCO PHARMA LLC | 20241121 | 2 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Macleods Pharmaceuticals Limited | 20241010 | 1 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS LINEZOLID tablets, for oral use Initial U.S. Approval:2000 | Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc. | 20240905 | 5 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION.LINEZOLID INJECTION Initial U.S. Approval: 2000 | Hp Halden Pharma AS | 20240717 | 3 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection, for intravenous use Initial U.S. Approval: 2000 | Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED | 20240706 | 12 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection for intravenous use Initial U.S. Approval: 2000 | Sandoz Inc | 20240701 | 18 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection Initial U.S. Approval: 2000 | Hp Halden Pharma AS | 20240528 | 4 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, tablets and oral suspension Initial U.S. Approval: 2000 | Hp Halden Pharma AS | 20240528 | 4 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, tablets and oral suspension Initial U.S. Approval: 2000 | Hp Halden Pharma AS | 20240528 | 4 |
| These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection for intravenous use Initial U.S. Approval: 2000 | Fresenius Kabi USA, LLC | HP Halden Pharma AS | 20240430 | 6 |
| These highlights do not include all the information needed to use LINEZOLID FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LINEZOLID FOR ORAL SUSPENSION. LINEZOLID for oral suspension Initial U.S. Approval: 2000 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20230915 | 2 |
| These highlights do not include all the information needed to use LINEZOLID FOR ORAL SUSPENSION safely and effectively. See full prescribing information for LINEZOLID FOR ORAL SUSPENSION. LINEZOLID for oral suspension Initial U.S. Approval: 2000 | American Health Packaging | Annora Pharma Private Limited | 20230818 | 1 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Alembic Pharmaceuticals Limited | 20230130 | 3 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20200826 | 17 |
| These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval:2000 | Novel Laboratories, Inc. | 20191221 | 2 |
| These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX ® (linezolid) injection, tablets and oral suspension Initial U.S. Approval: 2000 | Department of State Health Services, Pharmacy Branch | 20160209 | 1 |
| ZYVOX ® (linezolid) injection (linezolid) tablets (linezolid) for oral suspension | Rebel Distributors Corp | 20101222 | 1 |