Announcement under Regulation 30 (LODR)-Press Release / Media Release
We hereby inform that as per the USFDA letter with reference to the company's supplemental abbreviated new drug application (sANDA) received for review on August 20, 2018, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C; Act) for Ranitidine Injection USP, 25 mg/mL, 2 mL Single dose vials and 6 mL Multi-dose vials, the sANDA approval has been granted by the USFDA for a new fill size, 40 mL Pharmacy Bulk Package...12-12-2018