ANDA 65046, held by Hikma. Cefuroxime Sodium.
As of Nov 15, 2026, ANDA 65046 (Cefuroxime Sodium), held by Hikma, was first approved by FDA on Jan 9, 2004, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. Urinary Tract Infections caused by Escherichia coli and Klebsiella spp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 9, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefuroxime SodiumEQ 7.5GM BASE/VIAL · injectable;injection | Cefuroxime Sodium | Discontinued |
| Jul 7, 2021 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jul 7, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 16, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 6, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 25, 2008 | Supplement 3Labeling | Approved | None posted |
| Jan 9, 2004 | Original application | Approved | None posted |
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
