ANDA 076868

ELITE LABS INC

FDA Drug Application

Application #076868

Application Sponsors

ANDA 076868

ELITE LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	EQ 5MG BASE	0	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE
002	CAPSULE;ORAL	EQ 10MG BASE	0	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE
003	CAPSULE;ORAL	EQ 25MG BASE	0	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE
004	CAPSULE;ORAL	EQ 50MG BASE	0	LOXAPINE SUCCINATE	LOXAPINE SUCCINATE

FDA Submissions

	ORIG	1	AP	2005-08-04
LABELING; Labeling	SUPPL	6	AP	2008-09-08
LABELING; Labeling	SUPPL	7	AP	2008-11-19
LABELING; Labeling	SUPPL	8	AP	2015-04-29
LABELING; Labeling	SUPPL	9	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	8	Null	7
SUPPL	9	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76868
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOXAPINE SUCCINATE","activeIngredients":"LOXAPINE SUCCINATE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOXAPINE SUCCINATE","activeIngredients":"LOXAPINE SUCCINATE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOXAPINE SUCCINATE","activeIngredients":"LOXAPINE SUCCINATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOXAPINE SUCCINATE","activeIngredients":"LOXAPINE SUCCINATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOXAPINE SUCCINATE","submission":"LOXAPINE SUCCINATE","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOXAPINE SUCCINATE","submission":"LOXAPINE SUCCINATE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOXAPINE SUCCINATE","submission":"LOXAPINE SUCCINATE","actionType":"EQ 25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOXAPINE SUCCINATE","submission":"LOXAPINE SUCCINATE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)