FDA Approves ANDA203048 for Clindamycin Phosphate Injection by Rising

The U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) number ANDA203048 submitted by Rising for clindamycin phosphate injection products. The approval covers three injectable formulations packaged in plastic containers containing 5% dextrose, each with a different clindamycin phosphate strength: 6 mg base/mL (product 001), 12 mg base/mL (product 002), and 18 mg base/mL (product 003). All are prescription‑only. The FDA’s labeling submissions (submission numbers 1‑4, 8) were approved on May 14, 2020, and the original submission received approval on April 4, 2013. The products are classified as injectable and are not reference drugs. Rising is listed as the sponsor for this ANDA.