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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091526

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NDA 091526 describes DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Watson Labs Teva, Abraxis Pharm, 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 NDA: 091526

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiemetics
Antiparkinson Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091526

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 > 1 mL in 1 SYRINGE, GLASS

Summary for product number 001

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


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