ANDA 077361

ELITE LABS INC

FDA Drug Application

Application #077361

Documents

• Letter: 2006-08-07

Application Sponsors

ANDA 077361

ELITE LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	EQ 25MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE
002	CAPSULE;ORAL	EQ 50MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE
003	CAPSULE;ORAL	EQ 100MG BASE	0	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	2006-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2015-03-18
LABELING; Labeling	SUPPL	6	AP	2015-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2018-12-27	UNKNOWN

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77361
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIMIPRAMINE MALEATE","activeIngredients":"TRIMIPRAMINE MALEATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMIPRAMINE MALEATE","submission":"TRIMIPRAMINE MALEATE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TRIMIPRAMINE MALEATE","submission":"TRIMIPRAMINE MALEATE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TRIMIPRAMINE MALEATE","submission":"TRIMIPRAMINE MALEATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)