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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 083183

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NDA 083183 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Avet Lifesciences, Bel Mar, Dr Reddys, Gland, Hikma, Hospira, Lyphomed, Micro Labs, Pharmobedient, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms Inc, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication, and is included in seventy-seven NDAs. It is available from eighteen suppliers. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

Summary for 083183

Tradename:	DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 083183

Anesthetics, Local
Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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