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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040140

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NDA 040140 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Barr, Elkins Sinn, Halsey, Heather, 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, Sandoz, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Eurohlth Intl Sarl, Hospira, Lyphomed, Mylan Institutional, Watson Labs Teva, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Hi Tech Pharma, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication, and is included in seventy-three NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.

Summary for 040140

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

Pharmacology for NDA: 040140

Suppliers and Packaging for NDA: 040140

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 040140 ANDA Hospira, Inc. 0409-2290 0409-2290-31 10 CARTRIDGE in 1 CARTON (0409-2290-31) > 1 mL in 1 CARTRIDGE (0409-2290-03)
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 040140 ANDA General Injectables and Vaccines 52584-290 52584-290-31 1 CARTRIDGE in 1 BAG (52584-290-31) > 1 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Nov 20, 1998TE:APRLD:No


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