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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:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 22, 1984TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 22, 1984TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 22, 1984TE:ABRLD:No

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