NDA 216109, held by Hikma. Cefazolin Sodium.
As of Nov 13, 2026, NDA 216109 (Cefazolin Sodium), held by Hikma, was first approved by FDA on Oct 7, 2022, with 1 approved supplement and 0 published complete response letters.
Cefazolin for Injection is a cephalosporin antibacterial indicated for: Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved: Respiratory tract infections Urinary tract infections Skin and skin structure infections Biliary tract infections Bone and joint infections Genital infections Septicemia Endocarditis Perioperative prophylaxis in adult patients To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be…
| Dec 18, 2024 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Cefazolin SodiumEQ 2GM BASE/VIAL · powder;intravenous | Cefazolin Sodium | RxReference drug |
| Cefazolin SodiumEQ 3GM BASE/VIAL · powder;intravenous | Cefazolin Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
