Treats serious infections caused by susceptible anaerobic bacteria. ANDA 208084, held by Baxter Hlthcare Corp. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 208084 (Clindamycin Phosphate In 5% Dextrose In Plastic Container), held by Baxter Hlthcare Corp, was first approved by FDA on Jun 28, 2017, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin Injection USP in 5% Dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection USP in 5% Dextrose products are 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 |
|---|---|---|---|
| Jun 28, 2017 | Original application | Approved | None posted |
| Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 6MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 12MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Clindamycin Phosphate In 5% Dextrose In Plastic ContainerEQ 18MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Sep 18, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 18, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 28, 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
