An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208127
Company: BRECKENRIDGE

Products on ANDA 208127

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208127

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/03/2025	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208127

TRIMIPRAMINE MALEATE

CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE;ORAL	Prescription	No	AB	208127	BRECKENRIDGE
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE;ORAL	Prescription	No	AB	077361	ELITE LABS INC

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	208127	BRECKENRIDGE
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE;ORAL	Prescription	No	AB	077361	ELITE LABS INC

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	208127	BRECKENRIDGE
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	No	AB	077361	ELITE LABS INC

Top