Treats serious infections caused by susceptible strains of the designated microorganisms…. ANDA 65238, held by Hikma Farmaceutica. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65238 (Cefoxitin), held by Hikma Farmaceutica, was first approved by FDA on Mar 12, 2010, with 3 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 |
|---|---|---|---|
| Mar 12, 2010 | Original application | Approved | None posted |
| CefoxitinEQ 1GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
| CefoxitinEQ 2GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
| Dec 30, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 30, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 30, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 12, 2010 | 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
