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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 070118

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NDA 070118 describes DIPHEN, which is a drug marketed by Usl Pharma, Morton Grove, 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, Intl Medication, Able, Ani Pharms, Ascot, Chartwell Rx, Dr Reddys Labs Sa, Inwood Labs, Leading, Parke Davis, R And S Pharma, Specgx Llc, Strides Pharma Intl, Unichem, Upsher Smith Labs, Winder Labs Llc, Scherer Rp, and Chartwell Molecular, and is included in one hundred and nine NDAs. Additional details are available on the DIPHEN profile page.

The generic ingredient in DIPHEN is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for 070118

Tradename:	DIPHEN
Applicant:	Morton Grove
Ingredient:	diphenhydramine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 070118

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:	SYRUP;ORAL			Strength	12.5MG/5ML
Approval Date:	Oct 1, 1985	TE:		RLD:	No

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