DIPHENHYDRAMINE HYDROCHLORIDE

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.