Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205336

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NDA 205336 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, Annora Pharma, 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, 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 205336

Tradename:	DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Avet Lifesciences
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Pharmacology for NDA: 205336

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 205336

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

Suppliers and Packaging for NDA: 205336

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	205336	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-264	23155-264-41	25 VIAL, GLASS in 1 PACKAGE (23155-264-41) / 1 mL in 1 VIAL, GLASS (23155-264-31)
DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	INJECTABLE;INJECTION	205336	ANDA	REMEDYREPACK INC.	70518-4536	70518-4536-0	25 VIAL, GLASS in 1 PACKAGE (70518-4536-0) / 1 mL in 1 VIAL, GLASS (70518-4536-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Jun 24, 2025	TE:	AP	RLD:	No

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