| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION and DEXMEDETOMIDINE in DEXTROSE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION and DEXMEDETOMIDINE in DEXTROSE INJECTION. DEXMEDETOMIDINE injection, for intravenous use DEXMEDETOMIDINE in DEXTROSE injection, for intravenous use Initial U.S. Approval: 1999 | WG Critical Care, LLC | 20260602 | 14 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection for intravenous use. Initial U.S. Approval: 1999 | CIVICA, INC. | Wilshire Pharmaceuticals, Inc. | Gland Pharma Limited | 20260522 | 4 |
| These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. Precedex™ (dexmedetomidine hydrochloride) injection, f or intravenous use Precedex (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Henry Schein, Inc. | 20260521 | 9 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION . DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Mylan Institutional LLC | 20260520 | 4 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Gland Pharma Limited | 20260520 | 13 |
| These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PRECEDEX™ (dexmedetomidine hydrochloride) injection, for intravenous use PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Hospira, Inc. | Pfizer Healthcare India Private Limited | 20260520 | 59 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999 | Gland Pharma Limited | 20260519 | 4 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION . DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999 | Mylan Institutional LLC | 20260518 | 21 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Eugia US LLC | Interquim S.A de C.V | EUGIA PHARMA SPECIALITIES LIMITED | 20260512 | 15 |
| Sedexodine™ (dexmedetomidine hydrochloride) Injection 0.5 mg/mL Sterile Injectable Solution | MWI Veterinary Supply | 20260330 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999 | Baxter Healthcare Corporation | BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED | 20260320 | 9 |
| These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PRECEDEX TM (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Hospira, Inc. | 20260316 | 5 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Injection, for intravenous use Initial U.S. Approval: 1999 | Hikma Pharmaceuticals USA Inc. | 20260304 | 15 |
| Dexmedesed ® (dexmedetomidine hydrochloride) Sterile Injectable Solution-0.5 mg/mL For Intramuscular and Intravenous Use in Dogs For Intramuscular Use in Cats Sedative, Analgesic, Preanesthetic | Dechra Veterinary Products LLC | 20260217 | 9 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use Initial U.S. Approval: 1999 | Fresenius Kabi USA, LLC | 20260123 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION . DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Baxter Healthcare Company | Baxter Healthcare Corporation | 20251226 | 13 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION . DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Baxter Healthcare Company | Baxter Healthcare Corporation | 20251219 | 12 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Baxter Healthcare Company | Baxter Healthcare Corporation | 20251219 | 12 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use. Initial U.S. Approval: 1999 | ProPharma Distribution | 20251218 | 2 |
| Dexmedetomidine Hydrochloride | GRINDEKS Joint Stock Company | 20251216 | 3 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION, for intravenous use Initial U.S. Approval: 1999 | Precision Dose, Inc. | Corden Pharma SPA | 20251215 | 6 |
| These highlights do not include all the information needed to use IGALMI safely and effectively. See full prescribing information for IGALMI. IGALMI ® (dexmedetomidine) sublingual film, for sublingual or buccal use Initial U.S. Approval: 1999 | BioXcel Therapeutics, Inc. | Arx, LLC | 20251125 | 4 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use. Initial U.S. Approval: 1999 | ProPharma Distribution | 20251105 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | ProPharma Distribution | 20251104 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9 % SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9 % SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9 % SODIUM CHLORIDE injection, for intravenous use. Initial U.S. Approval: 1999 | Piramal Critical Care Inc | 20250925 | 7 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use. Initial U.S. Approval: 1999 | Piramal Critical Care Inc | 20250925 | 7 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use. Initial U.S. Approval: 1999 | Piramal Critical Care Inc | 20250923 | 6 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use Initial U.S. Approval: 1999 | Fresenius Kabi USA, LLC | 20250922 | 9 |
| Dexmedetomidine Hydrochloride 0.5 mg/mL | FELIX PHARMACEUTICALS PRIVATE LIMITED | 20250916 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Sagent Pharmaceuticals | 20250626 | 1 |
| Dexmedetomidine Hydrochloride Injection 0.5 mg/mL Sterile Injectable Solution | Parnell Technologies Pty Ltd | 20250515 | 4 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited | 20250512 | 14 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use. Initial U.S. Approval: 1999 | Hikma Pharmaceuticals USA Inc. | 20250512 | 15 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999 | Accord Healthcare Inc. | Intas Pharmaceuticals Ltd | 20250211 | 7 |
| These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX. PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection, for intravenous use Initial U.S. Approval: 1999 | Hospira, Inc. | 20250122 | 12 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection for intravenous use. Initial U.S. Approval: 1999 | Slayback Pharma LLC | Corden Pharma SpA | 20241212 | 10 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval:1999 | Somerset Therapeutics, LLC | Somerset Therapeutics Private Limited | 20240926 | 5 |
| Dexased™ | ASPEN VETERINARY RESOURCES®, LTD | 20240829 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection for intravenous use. Initial U.S. Approval: 1999 | Slayback Pharma LLC | Gland Pharma Limited | 20240816 | 7 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection for intravenous use. Initial U.S. Approval: 1999 | Wilshire Pharmaceuticals, Inc. | Gland Pharma Limited | 20240814 | 1 |
| DexmedVet™ | Cronus Pharma LLC | 20240601 | 4 |
| Sedexodine™ | MWI Animal Health | 20240531 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% Sodium Chloride Injection, for intravenous use Initial U.S. Approval: 1999 | Fresenius Kabi USA, LLC | 20240315 | 5 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use Initial U.S. Approval: 1999 | Avenacy Inc. | 20240315 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE Injection, for intravenous use. Initial U.S. Approval: 1999 | Medical Purchasing Solutions, LLC | 20240305 | 1 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Par Health USA, LLC | 20240201 | 34 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Sagent Pharmaceuticals | 20231006 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited | Maiva Pharma Private Limited | 20231006 | 18 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE in SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Sandoz Inc. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) | 20230612 | 15 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE INJECTION. DEXMEDETOMIDINE injection, for intravenous use. Initial U.S. Approval: 1999 | Meitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. | 20230605 | 6 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE Injection For intravenous use only. Initial U.S. Approval: 1999 | Medical Purchasing Solutions, LLC | 20230601 | 3 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1999 | Medical Purchasing Solutions, LLC | 20230601 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE injection for intravenous use Initial U.S. Approval: 1999 | Medical Purchasing Solutions, LLC | 20230523 | 3 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE Injection, for intravenous use. Initial U.S. Approval: 1999 | Medical Purchasing Solutions, LLC | 20230503 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE Injection, for intravenous use Initial U.S. Approval: 1999 | Akorn | 20220909 | 8 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% SODIUM CHLORIDE injection, for intravenous use. Initial U.S. Approval: 1999 | Dr.Reddy's Laboratories Inc | GLAND PHARMA LIMITED | 20220701 | 3 |
| Dexmedetomidine Hydrochloride Injection 0.5 mg/mL | BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA | Akorn Operating Company LLC | Exela Pharma Sciences, LLC. | 20210402 | 2 |
| These highlights do not include all the information needed to use DEXMEDETOMIDINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DEXMEDETOMIDINE HYDROCHLORIDE INJECTION. DEXMEDETOMIDINE HYDROCHLORIDE injection for intravenous use Initial U.S. Approval: 1999 | Sun Pharmaceuticals Industries, Inc. | GLAND PHARMA LIMITED | 20180820 | 4 |