Sun Pharmaceutical Industries announced that the USFDA has granted its subsidiary an approval for its ANDA for Promethazine Hydrochloride and Codeine Phosphate Oral Syrup, 6.25 mg/5 ml and 10mg/5ml.
This Promethazine Hydrochloride with Codeine Phosphate Oral Syrup is bioequivalent to Prometh w/ Codeine of Actavis Mid Atlantic LLC. This product has annual sales of approximately USD 16 million in the US.
This medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis).
Prometh is the registered trademark of Actavis Mid Atlantic LLC.