Last Updated: November 8, 2026

Details for New Drug Application (NDA): 085621

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NDA 085621 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma, 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, Annora Pharma, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Avet Lifesciences, Bel Mar, Dr Reddys, Gland, Hospira, Lyphomed, Micro Labs, Pharmobedient, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication, and is included in seventy-nine NDAs. It is available from twenty suppliers. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

Summary for 085621

Tradename:	DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Kv Pharm
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 085621

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:	ELIXIR;ORAL			Strength	12.5MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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