Sun Pharmaceutical Industries announced that its subsidiary has been granted an US FDA approval for its ANDA for Promethazine Hydrochloride and Codeine Phosphate oral syrup of 6.25mg/5 ml and 10 mg/5 ml strengths.
This is used to treat symptoms caused by common cold, flu, allergies or other breathing illnesses. The syrup is bio-equivalent to Prometh w/Codeine of Actavis Mid Atlantic LLC. The product has annual sales of about $16 million in US.
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