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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077361


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NDA 077361 describes TRIMIPRAMINE MALEATE, which is a drug marketed by Crossmedika Sa, Elite Labs Inc, and Usl Pharma, and is included in five NDAs. It is available from four suppliers. Additional details are available on the TRIMIPRAMINE MALEATE profile page.

The generic ingredient in TRIMIPRAMINE MALEATE is trimipramine maleate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.
Summary for 077361
Tradename:TRIMIPRAMINE MALEATE
Applicant:Elite Labs Inc
Ingredient:trimipramine maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077361
Medical Subject Heading (MeSH) Categories for 077361
Suppliers and Packaging for NDA: 077361
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMIPRAMINE MALEATE trimipramine maleate CAPSULE;ORAL 077361 ANDA Epic Pharma, LLC 42806-802 42806-802-30 30 CAPSULE in 1 BOTTLE (42806-802-30)
TRIMIPRAMINE MALEATE trimipramine maleate CAPSULE;ORAL 077361 ANDA Epic Pharma, LLC 42806-803 42806-803-30 30 CAPSULE in 1 BOTTLE (42806-803-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Aug 2, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 2, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Aug 2, 2006TE:ABRLD:No

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