| These highlights do not include all the information needed to use XATMEP ® safely and effectively. See full prescribing information for XATMEP. XATMEP (methotrexate) oral solution Initial U.S. Approval: 1953 | Azurity Pharmaceuticals, Inc. | 20260528 | 12 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20260527 | 8 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20260526 | 101 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Elite Laboratories, Inc. | 20260522 | 6 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Sun Pharmaceutical Industries, Inc. | Orion Corporation, Orion Pharma | Orion Corporation ORION PHARMA | 20260521 | 10 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20260520 | 105 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20260520 | 20 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260509 | 9 |
| These highlights do not include all the information needed to use TREXALL ® safely and effectively. See full prescribing information for TREXALL. TREXALL ® (methotrexate tablets), for oral use Initial U.S. Approval: 1953 | Teva Women's Health LLC | 20260508 | 13 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Aurobindo Pharma Limited | EUGIA Pharma Specialities Limited | 20260507 | 5 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Mylan Pharmaceuticals Inc. | 20260507 | 19 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Teva Pharmaceuticals USA, Inc. | 20260507 | 16 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | NuCare Pharmaceuticals, Inc. | 20260430 | 1 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260416 | 4 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Alembic Pharmaceuticals Limited | 20260416 | 1 |
| METHOTREXATE TABLETS. These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Golden State Medical Supply, Inc. | 20260415 | 10 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | A-S Medication Solutions | 20260204 | 15 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Safecor Health LLC | 20260130 | 2 |
| Methotrexate Tablets, USP Rx Only These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. Initial U.S. Approval: 1953 | AvPAK | 20260129 | 1 |
| Methotrexate Tablets These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Chartwell RX, LLC | 20251217 | 3 |
| These highlights do not include all the information needed to use JYLAMVO ® safely and effectively. See full prescribing information for JYLAMVO ® . JYLAMVO ® (methotrexate) oral solution Initial U.S. Approval: 1953 | SHORLA ONCOLOGY INC. | SHORLA PHARMA LTD. | SGS United Kingdom Limited | 20251215 | 10 |
| These highlights do not include all the information needed to use RASUVO ® safely and effectively. See full prescribing information for RASUVO. RASUVO (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953 | Medexus Pharma Inc. | 20251215 | 10 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Major Pharmaceuticals | 20250915 | 6 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Hospira, Inc. | Hospira Australia Pty Ltd | 20250822 | 17 |
| These highlights do not include all the information needed to use METHOTREXATE FOR INJECTION safely and effectively. See full prescribing information for METHOTREXATE FOR INJECTION . METHOTREXATE for Injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Fresenius Kabi USA, LLC | 20250819 | 6 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Mylan Institutional Inc. | 20250722 | 20 |
| METHOTREXATE-methotrexate for injection, powder, lyophilized, for solution Hikma Pharmaceuticals USA Inc. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METHOTREXATE FOR INJECTION safely and effectively. See full prescribing information for METHOTREXATE FOR INJECTION. METHOTREXATE for injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Hikma Pharmaceuticals USA Inc. | 20250717 | 8 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Teva Parenteral Medicines, Inc. | 20250715 | 11 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Eugia US LLC | Mylan Laboratories Limited | EUGIA Pharma Specialities Limited | 20250710 | 2 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Hospira, Inc. | Hospira Australia Pty Ltd | 20250630 | 6 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Hospira, Inc. | Hospira Australia Pty Ltd | 20250610 | 19 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Coupler LLC | 20250227 | 1 |
| These highlights do not include all the information needed to use OTREXUP™ safely and effectively. See full prescribing information for OTREXUP . OTREXUP (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953 | Antares Pharma, Inc. | Pharmascience Inc. | Sharp Packaging Services, LLC | NeoPharm Labs Inc | PPD Development, L.P. | 20250131 | 15 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Accord Healthcare, Inc. | Intas Pharmaceuticals Limited | 20250114 | 6 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | NuCare Pharmaceuticals, Inc. | 20250114 | 2 |
| Methotrexate tablet, USP | Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc. | 20241205 | 8 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20241001 | 9 |
| METHOTREXATE INJECTION, USP METHOTREXATE FOR INJECTION, USP | Hikma Pharmaceuticals USA Inc. | 20240905 | 2 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Proficient Rx LP | 20240801 | 1 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Alembic Pharmaceuticals Limited | 20240607 | 1 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20240604 | 3 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20240517 | 5 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20231207 | 100 |
| These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 20230815 | 100 |
| These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953 | Hikma Pharmaceuticals USA Inc. | 20230417 | 9 |
| Methotrexate Injection, USP | Fresenius Kabi USA, LLC | 20210324 | 6 |
| Methotrexate Tablets USP | A-S Medication Solutions | 20180823 | 7 |