ANDA 218817, held by Aurobindo Pharma Ltd. Cephalexin.
As of Nov 14, 2026, ANDA 218817 (Cephalexin), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 27, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cephalexin tablets are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes Otitis media due to susceptible isolates of Streptococcu pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella Catarrhalis. Skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus, and Streptococcus pyogenes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2024 | Original application | Approved | None posted |
| CephalexinEQ 250MG BASE · tablet;oral | Cephalexin | Rx |
| CephalexinEQ 500MG BASE · tablet;oral | Cephalexin | 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
