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| Exchange Received Time 12/12/2018 12:12:00 Exchange Disseminated Time 12/12/2018 12:12:08 Time Taken 00:00:08 | | 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 which was inadvertently mentioned as 25 mg/mL, 2 mL Single dose vials and 6 mL Multi-dose vials in the press note titled 'Liva Pharmaceuticals receives approval from the USFDA for its supplemental abbreviated new drug application (sANDA), Ranitidine Injection USP' released by the company yesterday, December 11, 2018. |
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