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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084936

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NDA 084936 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Sandoz, Leading Pharma Llc, Vangard, Watson Labs, Par Pharm, West Ward, Teva, Lupin Ltd, Sun Pharm Inds, Oxford Pharms, Novartis, Lederle, Usl Pharma, and Roxane, and is included in thirty-five 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. Twenty suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.

Summary for NDA: 084936

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 084936

Suppliers and Packaging for NDA: 084936

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride
TABLET;ORAL 084936 ANDA Sandoz Inc 0781-1762 0781-1762-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1762-01)
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride
TABLET;ORAL 084936 ANDA Sandoz Inc 0781-1762 0781-1762-10 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1762-10)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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