Treats serious infections caused by susceptible strains of the designated microorganisms…. ANDA 65414, held by Acs Dobfar. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65414 (Cefoxitin), held by Acs Dobfar, was first approved by FDA on Jun 12, 2009, 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 |
|---|---|---|---|
| Jun 12, 2009 | Original application | Approved | None posted |
| CefoxitinEQ 1GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
| CefoxitinEQ 2GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Rx |
| Oct 31, 2011 | Supplement 1Labeling | Approved | None posted |
| Jun 12, 2009 | 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
