Regulatory UpdatesSep 24, 2026•1 min read

DIPHENHYDRAMINE HYDROCHLORIDE

By the PharmaCountry team

FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.

The U.S. Food and Drug Administration (FDA) has recorded an approval for ANDA083183, an injectable formulation of diphenhydramine hydrochloride. Product details: the drug is administered by injection, presented as an injectable dosage form, with product number 001. It is not a reference drug and its marketing status is listed as discontinued. The active ingredient is diphenhydramine hydrochloride at a strength of 50 mg/mL. The submission was an original (ORIG) filing, submission number 1, and received an approved (AP) status on 12 October 1973. The sponsor for this application is Hikma.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#diphenhydramine #injection #ANDA #FDA #Hikma #approval