Last Updated: August 8, 2026

Details for New Drug Application (NDA): 219470

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NDA 219470 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 are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

Summary for 219470

Tradename:	DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Annora Pharma
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Pharmacology for NDA: 219470

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 219470

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

Suppliers and Packaging for NDA: 219470

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	ELIXIR;ORAL	219470	ANDA	Camber Pharmaceuticals, Inc.	31722-600	31722-600-11	1 BOTTLE in 1 CARTON (31722-600-11) / 118 mL in 1 BOTTLE
DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	ELIXIR;ORAL	219470	ANDA	Camber Pharmaceuticals, Inc.	31722-600	31722-600-31	10 CARTON in 1 BOX (31722-600-31) / 10 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ELIXIR;ORAL			Strength	12.5MG/5ML
Approval Date:	Jun 17, 2026	TE:	AA	RLD:	No

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