ANDA 65251, held by Samson Medcl. Cefuroxime Sodium.
As of Nov 15, 2026, ANDA 65251 (Cefuroxime Sodium In Plastic Container), held by Samson Medcl, was first approved by FDA on Dec 30, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2009 | Original application | Approved | None posted |
| Cefuroxime Sodium In Plastic ContainerEQ 75GM BASE/VIAL · injectable;injection | Cefuroxime Sodium | Discontinued |
| Cefuroxime Sodium In Plastic ContainerEQ 225GM BASE/VIAL · injectable;injection | Cefuroxime Sodium | Discontinued |
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
