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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
Moodys
Chubb
Cipla
QuintilesIMS
Deloitte
Merck
Queensland Health

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083745

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NDA 083745 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Leading Pharma Llc, Lederle, Lupin Ltd, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from eighteen suppliers. Additional details are available on the IMIPRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IMIPRAMINE HYDROCHLORIDE is imipramine hydrochloride. There are thirty-four drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 083745
Tradename:IMIPRAMINE HYDROCHLORIDE
Applicant:Sandoz
Ingredient:imipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 083745
Suppliers and Packaging for NDA: 083745
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 083745 ANDA Sandoz Inc 0781-1764 N 0781-1764-01
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 083745 ANDA Sandoz Inc 0781-1764 N 0781-1764-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
Baxter
US Army
UBS
US Department of Justice
Cantor Fitzgerald
Queensland Health
Johnson and Johnson

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