Treats serious infections caused by susceptible anaerobic bacteria. ANDA 214401, held by Hikma. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 214401 (Clindamycin Phosphate In Dextrose 5%), held by Hikma, was first approved by FDA on Apr 5, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% dextrose injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2023 | Original application | Approved | None posted |
| Clindamycin Phosphate In Dextrose 5%EQ 6MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Clindamycin Phosphate In Dextrose 5%EQ 12MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Clindamycin Phosphate In Dextrose 5%EQ 18MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
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
