Treats serious infections caused by susceptible strains of the designated microorganisms…. ANDA 65415, held by Acs Dobfar. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65415 (Cefoxitin), held by Acs Dobfar, was first approved by FDA on May 19, 2010, with 1 approved supplement 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 |
|---|---|---|---|
| May 19, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CefoxitinEQ 10GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
| May 2, 2012 | Supplement 2Labeling | Approved | None posted |
| May 19, 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
