Regulatory UpdatesSep 19, 2026•1 min read

FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet

By the PharmaCountry team

FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#PROMETHAZINE #tablet #ANDA #FDA #Oral #discontinued