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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
US Army
Queensland Health

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080817

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NDA 080817 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Barr, Elkins Sinn, Fosun Pharma, 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, 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 sixteen 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 080817
Pharmacology for NDA: 080817
Suppliers and Packaging for NDA: 080817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 080817 ANDA West-ward Pharmaceutical Corp. 0641-0376 N 0641-0376-25
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 080817 ANDA Rebel Distributors Corp 42254-190 E 42254-190-01

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Chinese Patent Office
US Department of Justice

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