Sun Pharmaceutical Industries has announced that the USFDA has granted its subsidiary an approval for its ANDA for Promcthazlne Hydrochloride and Codeine Phosphate oral syrup in strength of 6.25 mg/5 ml and 10mg/5ml.
This Promethazine Hydrochloride with Codeine Phosphate oral syrup is bioequlvaient to Prometh w/ Codeine of Actavis Mid Atlantic LLC. This product has annual sales of approximately US$ 16 million in the US. This medication is used to treat symptoms caused by the common cold, flu, allergies or other breathing illnesses.
The company made this announcement during the trading hours today, 18 March 2010.