NDA 208083, held by Baxter Hlthcare Corp. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 208083 (Clindamycin Phosphate In 0.9% Sodium Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Apr 20, 2017, with 6 approved supplements and 0 published complete response letters.
Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin, a lincosamide antibacterial indicated for the treatment of the following in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Clindamycin Phosphate In 0.9% Sodium ChlorideEQ 300MG BASE/50ML (EQ 6MG BASE/ML) · solution;intravenous | Clindamycin Phosphate | RxReference drug |
| Clindamycin Phosphate In 0.9% Sodium ChlorideEQ 600MG BASE/50ML (EQ 12MG BASE/ML) · solution;intravenous | Clindamycin Phosphate | RxReference drug |
| Clindamycin Phosphate In 0.9% Sodium ChlorideEQ 900MG BASE/50ML (EQ 18MG BASE/ML) · solution;intravenous | Clindamycin Phosphate | RxReference drug |
| Sep 1, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Sep 1, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Sep 1, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Feb 18, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Aug 1, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Dec 19, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 20, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
