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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077361
Company: ELITE LABS INC

Products on ANDA 077361

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	No
TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077361

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077361s000LTR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/27/2018	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/18/2015	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/18/2015	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/18/2015	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077361

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

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