ANDA 90701, held by Hikma. Ceftriaxone Sodium.
As of Nov 15, 2026, ANDA 90701 (Ceftriaxone Sodium), held by Hikma, was first approved by FDA on Oct 4, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ceftriaxone SodiumEQ 10GM BASE/VIAL · injectable;injection | Ceftriaxone Sodium | Rx |
| Jan 13, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 4, 2017 | 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
