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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 087846

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NDA 087846 describes TOFRANIL, which is a drug marketed by Novartis and Specgx Llc and is included in three NDAs. It is available from one supplier. Additional details are available on the TOFRANIL profile page.

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

Summary for 087846

Tradename:	TOFRANIL
Applicant:	Specgx Llc
Ingredient:	imipramine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 087846

Suppliers and Packaging for NDA: 087846

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	087846	ANDA	SpecGx LLC	0406-9920	0406-9920-01	100 TABLET, SUGAR COATED in 1 BOTTLE (0406-9920-01)
IMIPRAMINE HYDROCHLORIDE	imipramine hydrochloride	TABLET;ORAL	087846	ANDA	SpecGx LLC	0406-9920	0406-9920-03	30 TABLET, SUGAR COATED in 1 BOTTLE (0406-9920-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 22, 1984	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 22, 1984	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 22, 1984	TE:	AB	RLD:	No

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