ANDA 65082, held by Sun Pharm Inds Ltd. Cefpodoxime Proxetil.
As of Nov 15, 2026, ANDA 65082 (Cefpodoxime Proxetil), held by Sun Pharm Inds Ltd, was first approved by FDA on May 31, 2002, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2002 | Original application | Approved |
| Cefpodoxime ProxetilEQ 50MG BASE/5ML · for suspension;oral | Cefpodoxime Proxetil | Discontinued |
| Cefpodoxime ProxetilEQ 100MG BASE/5ML · for suspension;oral | Cefpodoxime Proxetil | Discontinued |
| Apr 25, 2008 | Supplement 10Labeling | Approved | None posted |
| Jul 12, 2004 | Supplement 4Labeling | Approved | None posted |
| May 31, 2002 | Original application | Approved |
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