FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet

The U.S. Food and Drug Administration (FDA) has issued an Abbreviated New Drug Application (ANDA) number ANDA084080 for a promethazine hydrochloride product submitted by TABLICAPS. The product is an oral tablet containing 12.5 mg of promethazine hydrochloride, classified under the route "ORAL" and dosage form "TABLET". The sponsor indicated that the product is not a reference drug and is listed with a marketing status of "Discontinued". No reference standard was provided for this submission.