Last Updated: September 24, 2026

Details for New Drug Application (NDA): 080586

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NDA 080586 describes DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Abraxis Pharm, Dr Reddys, Fresenius Kabi Usa, and Intl Medication, and is included in four NDAs. It is available from one supplier. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE 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 080586

Tradename:	DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:	Abraxis Pharm
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080586

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

Profile for product number 002

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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