Caplin Point Laboratories has informed that it enclosed Press Release regarding receipt of final approval by Subsidiary, Caplin Steriles Limited, from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Potassium Phosphates Injection USP, (phosphorus 3 mmol/mL and potassium 4.4 mEq/mL in 5 mL, 15 mL and 50 mL Vials), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC (NDA 212832).
The above information is a part of company’s filings submitted to BSE.
