ANDA 62422, held by Baxter Hlthcare. Cephalothin Sodium.
As of Nov 15, 2026, ANDA 62422 (Cephalothin Sodium W/ Sodium Chloride In Plastic Container, Cephalothin Sodium W/ Dextrose In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Jan 31, 1984, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1984 | Original application | Approved | None posted |
| Cephalothin Sodium W/ Sodium Chloride In Plastic ContainerEQ 20MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Cephalothin Sodium W/ Sodium Chloride In Plastic ContainerEQ 40MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 20MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 40MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 20MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 40MG BASE/ML · injectable;injection | Cephalothin Sodium | Discontinued |
| Jul 16, 1991 | Supplement 12Labeling | Approved | None posted |
| Jan 31, 1984 | 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
