Potassium Chloride Oral Solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium rich foods or.
Strides Pharma Science Ltd today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Potassium Chloride Oral Solution USP, 40 from the USFDA.
Granules India announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned
foreign subsidiary of Granules India, for Potassium Chloride Oral Solution USP, 20 mEq/15 mL (10%)
and 40 mEq/15 mL (20%).
It is bioequivalent to the reference listed drug product (RLD), Potassium Chloride
Oral Solution, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), of Genus Lifesciences, Inc.
The product would
be available in bottle of 473 ml and is expected to be launched shortly.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without
metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose
The US drug regulator has approved the ANDA filed by Granules Pharmaceuticals, Inc, a wholly owned foreign arm of Granules India, for potassium chloride oral solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%).
The product is bio-equivalent to the reference listed drug product (RLD), potassium chloride oral solution, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), of Genus Lifesciences, Inc. The product would be available in bottle of 473 ml and is expected to be launched shortly.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. Granules now has a total of 36 ANDA approvals from USFDA (35 final approvals and 1 tentative approvals).