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.
규제 업데이트2026년 9월 24일•1분 읽기
DIPHENHYDRAMINE HYDROCHLORIDE
FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.
PharmaCountry 팀이 정리했습니다 · 출처: FDA.gov
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