| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | AVET LIFESCIENCES PRIVATE LIMITED | GLAND PHARMA LIMITED | Emcure Pharmaceuticals Limited | 20260527 | 21 |
| 87712-001-01 PADORO TRANEXAMIC ACID VITAMIN C SERUM | PUTIAN DREAM BOX E-COMMERCE CO., LTD | 20260522 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Bioindustria Laboratorio Italiano Medicinali S.p.A | 20260512 | 3 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | AVET LIFESCIENCES PRIVATE LIMITED | Emcure Pharmaceuticals Limited | GLAND PHARMA LIMITED | 20260410 | 13 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | American Health Packaging | 20260303 | 3 |
| Tranexamic Acid Tablet, USP Rx Only These highlights do not include all the information needed to use TRANEXAMIC ACID USP TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID USP TABLETS. Initial U.S. Approval: 1986 | AvPAK | 20260112 | 3 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | ADVAGEN PHARMA LIMITED | Rubicon Research Limited | 20260107 | 5 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Micro Labs Limited | 20251215 | 13 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Amneal Pharmaceuticals LLC | 20251114 | 14 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Northstar Rx LLC | Emcure Pharmaceuticals Limited | 20251113 | 2 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID Injection for intravenous use Initial U.S. Approval:1986 | XGen Pharmaceuticals DJB, Inc. | 20251106 | 10 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID USP TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID USP TABLETS. TRANEXAMIC ACID, USP tablets, for oral use Initial U.S. Approval: 1986 | Nordic Pharma, Inc. | Ferring International Center S.A. | Mikart, LLC | 20250929 | 7 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION . TRANEXAMIC ACID Injection, for intravenous use Initial U.S. Approval: 1986 | REMEDYREPACK INC. | 20250925 | 2 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Gland Pharma Limited | 20250925 | 9 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Bryant Ranch Prepack | 20250924 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Apotex Corp. | Apotex Inc. | 20250922 | 11 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Sagent Pharmaceuticals | 20250919 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS . TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | ANI Pharmaceuticals, Inc. | 20250919 | 4 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED | 20250918 | 9 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Mylan Institutional LLC | 20250908 | 22 |
| These highlights do not include all the information needed to use CYKLOKAPRON safely and effectively. See full prescribing information for CYKLOKAPRON. CYKLOKAPRON ® (tranexamic acid) injection, for intravenous use Initial U.S. Approval: 1986 | Pfizer Laboratories Div Pfizer Inc | Pfizer Manufacturing Belgium NV | 20250903 | 34 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safetly and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Provepharm Inc. | Immacule Lifesciences Private Limited | Hunan Dongting Pharmaceutical Co., Ltd. | Analytical Solutions | 20250812 | 5 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Dr. Reddy's Laboratories Inc. | Steril-Gene Life Sciences (P) Ltd | 20250801 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Actavis Pharma, Inc. | 20250715 | 18 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION . TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Amneal Pharmaceuticals Private Limited | 20250530 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Avenacy Inc. | 20250328 | 2 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Proficient Rx LP | 20250301 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Nexus Pharmaceuticals LLC | 20250226 | 5 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | HP Halden Pharma AS | 20250114 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID Injection, for intravenous use Initial U.S. Approval: 1986 | Caplin Steriles Limited | 20250103 | 7 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Fresenius Kabi USA, LLC | HP Halden Pharma AS | 20241115 | 3 |
| Rx only | Emcure Pharmaceuticals Limited | 20241028 | 1 |
| 2194ec64-01ed-7dec-e063-6394a90abfe3 | Guangdong Youbaijia Cosmetic Industry Co., Ltd | 20240908 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Sagent Pharmaceuticals | 20240814 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS . TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Bryant Ranch Prepack | 20240808 | 106 |
| 84251-002 | GUANGZHOU SHANGPIN BIOTECHNOLOGY CO.,LTD | 20240725 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Gland Pharma Limited | 20240419 | 3 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Avenacy, Inc. | 20240315 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID Injection, for intravenous use Initial U.S. Approval: 1986 | Armas Pharmaceuticals Inc. | Caplin Steriles Limited | 20240206 | 1 |
| TRANEXAMIC ACID INJECTION, USP 1,000mg PER 10mL (100mg/mL) 10mL VIAL | HF Acquisition Co LLC, DBA HealthFirst | 20240130 | 3 |
| These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Bryant Ranch Prepack | 20240115 | 103 |
| Rosacea Therapy Moisturizing Cream | PSODEX USA INC | 20231229 | 2 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID TABLETS safely and effectively. See full prescribing information for TRANEXAMIC ACID TABLETS. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Aurobindo Pharma Limited | 20231207 | 1 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE INJECTION . TRANEXAMIC ACID IN 0.7% SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Amneal Pharmaceuticals Private Limited | 20231130 | 8 |
| These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986 | Bryant Ranch Prepack | 20231106 | 101 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous use Initial U.S. Approval: 1986 | Sagent Pharmaceuticals | 20230620 | 1 |
| These highlights do not include all the information needed to use Tranexamic Acid Injection safely and effectively. See full prescribing information for Tranexamic Acid Injection. Tranexamic Acid Injection for Intravenous use Initial U.S. Approval:1986 | A-S Medication Solutions | 20210415 | 4 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID INJECTION, for intravenous use Initial U.S. Approval: 1986 | American Regent, Inc. | 20210301 | 19 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION . TRANEXAMIC ACID Injection, for intravenous use Initial U.S. Approval: 1986 | Baxter Healthcare Corporation | 20210226 | 8 |
| 7b9adc93-0d15-48d5-90f4-462d95643349 | Reviresco Co., Ltd. | Cosmax, Inc. | 20191224 | 3 |
| e451eac7-c186-4df2-a1e4-1bfd3dcef557 | Reviresco Co., Ltd. | Cosmax, Inc. | 20191224 | 2 |
| These highlights do not include all the information needed to use TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION. TRANEXAMIC ACID IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1986 | Exela Pharma Sciences, LLC | 20190422 | 1 |
| ad87d4f8-e195-40a8-b17b-36e8e5817719 | Reviresco Co., Ltd. | EZEKIELCOSMETIC CO.,LTD | 20181128 | 2 |
| a46ac0e4-f657-4510-aaf1-ae1a52a5d670 | SKIN M.D. KOREA | 20150306 | 1 |