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Serving leading biopharmaceutical companies globally:

Covington
Teva
Harvard Business School
Accenture
US Department of Justice
Chubb
Mallinckrodt
Cerilliant
Dow
UBS

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 081048

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NDA 081048 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Leading Pharma Llc, Lederle, Lupin Ltd, Mallinckrodt Inc, Oxford Pharms, Par Pharm, Roxane, Sandoz, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 081048
Tradename:IMIPRAMINE HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:imipramine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 081048
Suppliers and Packaging for NDA: 081048
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 081048 ANDA Sun Pharmaceutical Industries, Inc. 53489-330 53489-330-07 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-330-07)
IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 081048 ANDA Sun Pharmaceutical Industries, Inc. 53489-330 53489-330-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-330-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 5, 1990TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Cerilliant
Medtronic
Boehringer Ingelheim
Fish and Richardson
Julphar
Teva
Daiichi Sankyo

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