| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Redpharm Drug | 20260527 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | PD-Rx Pharmaceuticals, Inc. | 20260429 | 27 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | REMEDYREPACK INC. | 20260403 | 9 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20260307 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20260307 | 10 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998 | Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | 20260306 | 23 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20260305 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20260305 | 17 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Preferred Pharmaceuticals, Inc. | 20260113 | 6 |
| Montelukast Sodium Tablets Rx Only These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. Initial U.S. Approval: 1998 | AvPAK | 20260108 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Redpharm Drug | 20251230 | 3 |
| Montelukast Sodium CHEWABLE Tablets, 4 mg and 5 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Chartwell RX, LLC | 20251217 | 3 |
| MONTELUKAST SODIUM TABLETS These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | AvKARE | 20251216 | 22 |
| MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS Rx Only These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | AvPAK | 20251029 | 8 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | PD-Rx Pharmaceuticals, Inc. | 20251016 | 22 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | PD-Rx Pharmaceuticals, Inc. | 20251009 | 24 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Amneal Pharmaceuticals LLC | 20250912 | 18 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | Ajanta Pharma Ltd., Dahej | 20250829 | 20 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Preferred Pharmaceuticals Inc. | 20250813 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998 | Preferred Pharmaceuticals Inc. | 20250813 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Preferred Pharmaceuticals, Inc. | 20250813 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Cardinal Health 107, LLC | 20250702 | 6 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Major Pharmaceuticals | 20250619 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Sandoz Inc | 20250613 | 15 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals, Inc. | 20250530 | 1 |
| These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) tablets, for oral use SINGULAIR ® (montelukast sodium) chewable tablets, for oral use SINGULAIR ® (montelukast sodium) oral granules Initial U.S. Approval: 1998 | Organon LLC | 20250430 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | 20250418 | 20 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V | 20250313 | 8 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Quallent Pharmaceuticals Health LLC | Hetero Labs Limited Unit V | 20250228 | 2 |
| MONTELUKAST SODIUM | Direct_Rx | 20250122 | 3 |
| MONTELUKAST SODIUM | DIRECT RX | 20250120 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals,Inc. | 20241230 | 6 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Coupler LLC | 20241205 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS . MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Coupler LLC | 20241113 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | American Health Packaging | 20241031 | 9 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20241007 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Redpharm Drug | 20241004 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20240808 | 104 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Redpharn Drug, Inc | Redpharm Drug, Inc | 20240807 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Rising Pharma Holdings, Inc. | Graviti Pharmaceuticals Private Limited | 20240726 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals,Inc. | 20240717 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals,Inc. | 20240717 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals,Inc. | 20240710 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20240403 | 102 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited | 20240330 | 10 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Aurobindo Pharma Limited | Aurolife Pharma LLC | 20240330 | 21 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 | Westminster Pharmaceuticals, LLC | Anbison Lab. Ltd. | Hangzhou Minsheng Binjiang Pharma. | 20240130 | 7 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20231211 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20231102 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20231101 | 8 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | RPK Pharmaceuticals, Inc. | 20231025 | 5 |
| These highlights do not include all the information needed to use Montelukast Sodium safely and effectively. See full prescribing information for Montelukast Sodium. Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20231001 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | RPK Pharmaceuticals, Inc. | 20230911 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | RPK Pharmaceuticals, Inc. | 20230911 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmaceuticals,Inc. | 20230714 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Lannett Company, Inc. | 20230711 | 37 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval 1998 | Macleods Pharmaceuticals Limited | 20230706 | 8 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Unichem Pharmaceuticals (USA), Inc. | 20230612 | 17 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | RPK Pharmaceuticals, Inc. | 20230607 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES. MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20230603 | 8 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20230301 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Macleods Pharmaceuticals Limited | 20230121 | 11 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | XLCare Pharmaceuticals Inc. | Evaric Pharmaceuticals Inc | 20230117 | 2 |
| MONTELUKAST SODIUM | DIRECT RX | 20230111 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS . MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Dr.Reddy's Laboratories Limited | 20221030 | 24 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | NuCare Pharmceuticals,Inc. | NuCare Pharmaceuticals,Inc. | 20221007 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM tablets and MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Strides Pharma Science Limited | 20220809 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20220601 | 4 |
| These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20220502 | 6 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | RPK Pharmaceuticals, Inc. | 20220330 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | BluePoint Laboratories | Macleods Pharmaceuticals Limited | 20220310 | 7 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST sodium tablets and MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20220208 | 1002 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Accord Healthcare Inc. | Intas Pharmaceuticals Ltd | Intas Pharmaceuticals Limited | 20220101 | 15 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20211223 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998 | Bryant Ranch Prepack | 20211223 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20211009 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20210701 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Aphena Pharma Solutions - Tennessee, LLC | 20210626 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V | 20210618 | 6 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20210616 | 13 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | A-S Medication Solutions | 20210614 | 5 |
| These highlights do not include all the information needed to use MONTELUKAST sodium tablets, chewable tablets and oral granules safely and effectively. See full prescribing information for MONTELUKAST sodium tablets, chewable tablets and oral granules. MONTELUKAST sodium tablets, chewable tablets and oral granules Initial U.S. Approval: 1998 | Proficient Rx LP | 20210101 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST sodium tablets, chewable tablets and oral granules safely and effectively. See full prescribing information for MONTELUKAST sodium tablets, chewable tablets and oral granules. MONTELUKAST sodium tablets, chewable tablets and oral granules Initial U.S. Approval: 1998 | Proficient Rx LP | 20210101 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 20200615 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM Tablets, for oral use Initial U.S. Approval: 1998 | Hangzhou Minsheng Binjiang Pharm | Anbison Lab. Ltd. | Hangzhou Minsheng Binjiang Pharma | 20200521 | 3 |
| MONTELUKAST SODIUM | DIRECT RX | 20200121 | 2 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Proficient Rx LP | 20191101 | 3 |
| These highlights do not include all the information needed to use Montelukast Sodium safely and effectively. See full prescribing information for Montelukast Sodium. Montelukast Sodium Tablets Initial U.S. Approval: 1998 | Proficient Rx LP | 20191101 | 4 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 | Proficient Rx LP | 20191101 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST sodium tablets, chewable tablets and oral granules Initial U.S. Approval: 1998 | Proficient Rx LP | 20191001 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited-FTO3 | 20190830 | 15 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998 | Aphena Pharma Solutions - Tennessee, LLC | 20180911 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST sodium tablets, chewable tablets Initial U.S. Approval: 1998 | Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals | 20180816 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM tablets and MONTELUKAST SODIUM chewable tablets, for oral use. Initial U.S. Approval: 1998 | Aphena Pharma Solutions - Tennessee, LLC | 20180426 | 1 |
| Warning Letter | Food and Drug Administration | 20171205 | 1 |
| 468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998 | Contract Pharmacy Services-PA | Coupler Enterprises | 20170921 | 1 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets and chewable tablets, for oral use Initial U.S. Approval: 1998 | International Laboratories, LLC | 20170609 | 14 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998 | Carilion Materials Management | 20160806 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998 | Carilion Materials Management | 20160806 | 5 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. MONTELUKAST sodium tablets and MONTELUKAST chewable tablets, for oral use Initial U.S. Approval: 1998 | Carilion Materials Management | 20160805 | 3 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd. | Anbison laboratory Co. Ltd. | Hangzhou Minsheng Binjiang Pharma | 20151112 | 2 |
| These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 | West ward Pharmaceutical Corp | Unimark Remedies Ltd. | Alkem Laboratories Limited. | Kemwell Biopharma Private Limited | 20150624 | 3 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. MONTELUKAST sodium tablets and MONTELUKAST chewable tablets, for oral use Initial U.S. Approval: 1998 | Carilion Materials Management | 20150508 | 7 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 1998 | State of Florida DOH Central Pharmacy | 20150110 | 1 |
| These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium tablets. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998 | Aurobindo Pharma Limited | 20141224 | 6 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 1998 | ReadyMeds | 20140630 | 17 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 1998 --------- RECENT MAJOR CHANGES --------------- Warnings and Precautions Neuropsychiatric Events (5.4) 03/2013 | Aphena Pharma Solutions - Tennessee, LLC | 20140423 | 1 |
| These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium tablets. montelukast sodium tablets Initial U.S. Approval: 1998 | State of Florida DOH Central Pharmacy | 20140305 | 1 |
| These highlights do not include all the information needed to use montelukast sodium tablets safely and effectively. See full prescribing information for montelukast sodium tablets. Montelukast Sodium Tablets Initial U.S. Approval: 1998 | Aidarex Pharmaceuticals LLC | 20140115 | 1 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 1998 | State of Florida DOH Central Pharmacy | 20130925 | 1 |
| These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998 | MedVantx, Inc. | Teva Pharmaceuticals USA Inc | Blenheim Pharmacal, Inc. | 20121228 | 1 |
| These highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 1998 | Physicians Total Care, Inc. | 20120914 | 2 |
| These highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 1998 | Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp. | 20120717 | 1 |
| These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules Initial U.S. Approval: 1998 | Physicians Total Care, Inc. | 20120216 | 1 |
| These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) tablets, chewable tablets, and oral granules Initial U.S. Approval: 1998 | Rebel Distributors Corp | 20101201 | 1 |
| SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES | Dispensing Solutions Inc. | 20100301 | 1 |