FDA Approves Gemcitabine Injection (ANDA079183)

The U.S. Food and Drug Administration has issued an approval for the Abbreviated New Drug Application (ANDA) number 079183 for the injectable chemotherapy agent gemcitabine, marketed by Hospira, Inc. The approval covers gemcitabine hydrochloride for intravenous use, identified by package NDC 0409-0187-01. The application’s submission history includes an original submission (submission 1) received on 15 November 2010, followed by several labeling supplements (submissions 4, 5, 7, 8, and 14). The most recent labeling supplement was submitted on 24 September 2024. The product is classified as a prescription human drug, with a dosage form of injectable gemcitabine hydrochloride equivalent to 2 g base per vial.