Treats serious infections caused by susceptible strains of the designated microorganisms…. ANDA 65239, held by Hikma Farmaceutica. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65239 (Cefoxitin), held by Hikma Farmaceutica, was first approved by FDA on Feb 26, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Treatment Cefoxitin for Injection, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CefoxitinEQ 10GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
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
