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Details for New Drug Application (NDA): 084640

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NDA 084640 describes DIPHEN, which is a drug marketed by Morton Grove, Usl Pharma, Whiteworth Town Plsn, Elkins Sinn, Pioneer Pharms, Mutual Pharm, Impax Labs, Cumberland Swan, Pharm Assoc, Halsey, Hi Tech Pharma, Eurohlth Intl Sarl, Alra, Kv Pharm, Bel Mar, Heather, Pvt Form, Watson Labs, Vangard, Sandoz, Nexgen Pharma Inc, Roxane, Lederle, Purepac Pharm, Barr, Lannett, Superpharm, Hospira, Cenci, Newtron Pharms, Perrigo, Ivax Sub Teva Pharms, App Pharms, Lyphomed, Hikma Intl Pharms, Watson Labs Inc, Teva, Bundy, Anabolic, LNK, Wyeth Ayerst, Naska, Mk Labs, Sun Pharm Inds, Valeant Pharm Intl, Alpharma Us Pharms, Mylan Institutional, Fresenius Kabi Usa, Abraxis Pharm, Intl Medication, Inwood Labs, Ani Pharms Inc, Parke Davis, Ascot, R And S Pharma, Par Pharm, Mylan, Hikma Pharms Llc, Able, and Scherer Rp, and is included in ninety-eight NDAs. Additional details are available on the DIPHEN profile page.

The generic ingredient in DIPHEN is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for NDA: 084640

Tradename:
DIPHEN
Applicant:
Usl Pharma
Ingredient:
diphenhydramine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Antiparkinson Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:ELIXIR;ORALStrength12.5MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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