ANDA 65503, held by Hospira Inc. Cefuroxime Sodium.
As of Nov 15, 2026, ANDA 65503 (Cefuroxime Sodium), held by Hospira Inc, was first approved by FDA on Oct 15, 2008, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefuroxime SodiumEQ 1.5GM BASE/VIAL · injectable;injection | Cefuroxime Sodium | Discontinued |
| May 20, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 15, 2008 | 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
