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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 208127


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NDA 208127 describes TRIMIPRAMINE MALEATE, which is a drug marketed by Breckenridge, Elite Labs Inc, and Usl Pharma, and is included in five NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.
Summary for 208127
Tradename:TRIMIPRAMINE MALEATE
Applicant:Breckenridge
Ingredient:trimipramine maleate
Patents:0
Pharmacology for NDA: 208127
Medical Subject Heading (MeSH) Categories for 208127
Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic
Suppliers and Packaging for NDA: 208127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMIPRAMINE MALEATE trimipramine maleate CAPSULE;ORAL 208127 ANDA Breckenridge Pharmaceutical, Inc. 51991-944 51991-944-01 100 CAPSULE in 1 BOTTLE (51991-944-01)
TRIMIPRAMINE MALEATE trimipramine maleate CAPSULE;ORAL 208127 ANDA Breckenridge Pharmaceutical, Inc. 51991-944 51991-944-33 30 CAPSULE in 1 BOTTLE (51991-944-33)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Apr 15, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Apr 15, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Apr 15, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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