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Last Updated: March 19, 2024

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. 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 22, 1984TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 22, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 22, 1984TE:ABRLD:Yes

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