United States Food & Drug Administration has granted Ajanta Pharma 10 final approvals and 2 tentative approvals for its abbreviated new drug application, it said, adding another 14 ANDAs are pending approval from the USFDA.
"The company has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market Memantine Hydrochloride Tablets, 5mg and 10mg (ANDA 203175)," Aurobindo Pharma said in a BSE filing.
"Jubilant Life has received abbreviated new drug application (ANDA) final approval from the USFDA for Memantine hydrochloride tablets USP, 5 mg and 10 mg," the pharmaceuticals and life sciences company said in its filing.