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Last Updated: April 2, 2026

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. 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 are twenty-three drug master file entries for this compound. Seventeen 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
Pharmacology for NDA: 091526
Mechanism of ActionHistamine H1 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 091526
Anesthetics, Local
Anti-Allergic Agents
Antiemetics
Histamine H1 Antagonists
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical
Suppliers and Packaging for NDA: 091526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 091526 ANDA Fresenius Kabi USA, LLC 76045-102 76045-102-10 24 BLISTER PACK in 1 CARTON (76045-102-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-102-00) / 1 mL in 1 SYRINGE, GLASS
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE diphenhydramine hydrochloride INJECTABLE;INJECTION 091526 ANDA Fresenius Kabi USA, LLC 76045-235 76045-235-10 24 BLISTER PACK in 1 CARTON (76045-235-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-235-01) / 1 mL in 1 SYRINGE, GLASS

Profile for product number 001

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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