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Details for New Drug Application (NDA): 088034

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NDA 088034 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by 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, 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 NDA: 088034

Tradename:
DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:
Vangard
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:CAPSULE;ORALStrength25MG
Approval Date:Oct 27, 1982TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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