ANDA 202674

UNICHEM LABS LTD

FDA Drug Application

Application #202674

Application Sponsors

ANDA 202674

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
002	TABLET;ORAL	EQ 50MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
003	TABLET;ORAL	EQ 100MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
004	TABLET;ORAL	EQ 200MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
005	TABLET;ORAL	EQ 300MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE
006	TABLET;ORAL	EQ 400MG BASE	0	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-08
LABELING; Labeling	SUPPL	4	AP	2017-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2017-07-03	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202674
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/03\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-07-03
        )

)