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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 081048

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NDA 081048 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from eleven 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. Eleven 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 5, 1990	TE:		RLD:	No

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