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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208127

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NDA 208127 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 two 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 NDA: 208127

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 208127

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. 51991-945 51991-945-01 100 CAPSULE in 1 BOTTLE (51991-945-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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