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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 091526

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NDA 091526 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. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 091526
Tradename:DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:diphenhydramine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091526
Anesthetics, Local
Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Mar 26, 2013TE:APRLD:No

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Medtronic

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.

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