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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
US Army
Johnson and Johnson

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070497

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NDA 070497 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 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. Eighteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 070497

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength12.5MG/5ML
Approval Date:Apr 25, 1989TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Express Scripts
US Department of Justice

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