Last Updated: September 24, 2026

Details for New Drug Application (NDA): 011838

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NDA 011838 describes TOFRANIL, which is a drug marketed by Novartis and Specgx Llc and is included in three NDAs. Additional details are available on the TOFRANIL profile page.

The generic ingredient in TOFRANIL is imipramine pamoate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.

Summary for 011838

Tradename:	TOFRANIL
Applicant:	Novartis
Ingredient:	imipramine hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	12.5MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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