The company has received abbreviated new drug approval from the United States Food and Drug Administration (USFDA) for Flumazenil injection USP 0.5 mg/5mL and 1 mg/10 mL multiple dose vials, Claris Lifesciences said in a BSE filing.
The approval has come for the same plant where FDA had recently completed prior approval inspection, it added.
"With this approval the company now has a total of 16 approvals and 23 under approval ANDAs" , Claris Lifesciences said.
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