ANDA 075713

SUN PHARM INDS INC

FDA Drug Application

Application #075713

Documents

• Other: 2015-09-16

Application Sponsors

ANDA 075713

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	CLOZAPINE	CLOZAPINE
002	TABLET;ORAL	100MG	0	CLOZAPINE	CLOZAPINE
003	TABLET;ORAL	50MG	0	CLOZAPINE	CLOZAPINE
004	TABLET;ORAL	200MG	0	CLOZAPINE	CLOZAPINE

FDA Submissions

	ORIG	1	AP	2002-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2005-08-19
LABELING; Labeling	SUPPL	6	AP	2005-08-19
LABELING; Labeling	SUPPL	7	AP	2006-03-13
LABELING; Labeling	SUPPL	9	AP	2006-06-30
LABELING; Labeling	SUPPL	11	AP	2006-10-13
LABELING; Labeling	SUPPL	12	AP	2006-10-13
LABELING; Labeling	SUPPL	15	AP	2017-11-07
LABELING; Labeling	SUPPL	18	AP	2008-08-19
LABELING; Labeling	SUPPL	22	AP	2009-04-17
LABELING; Labeling	SUPPL	25	AP	2010-02-25
LABELING; Labeling	SUPPL	27	AP	2011-04-05
LABELING; Labeling	SUPPL	28	AP	2011-07-11
LABELING; Labeling	SUPPL	29	AP	2011-12-27
LABELING; Labeling	SUPPL	35	AP	2014-06-26	STANDARD
REMS; REMS	SUPPL	36	AP	2015-09-15
LABELING; Labeling	SUPPL	38	AP	2017-06-29	STANDARD
LABELING; Labeling	SUPPL	39	AP	2017-06-29	STANDARD
LABELING; Labeling	SUPPL	41	AP	2017-06-29	STANDARD
REMS; REMS	SUPPL	45	AP	2019-01-16
REMS; REMS	SUPPL	50	AP	2021-02-18
REMS; REMS	SUPPL	54	AP	2021-07-29
REMS; REMS	SUPPL	55	AP	2021-11-10

Submissions Property Types

SUPPL	5	Null	0
SUPPL	15	Null	29
SUPPL	25	Null	7
SUPPL	27	Null	8
SUPPL	29	Null	15
SUPPL	35	Null	15
SUPPL	36	Null	15
SUPPL	38	Null	15
SUPPL	39	Null	15
SUPPL	41	Null	15
SUPPL	45	Null	7
SUPPL	50	Null	7
SUPPL	54	Null	7
SUPPL	55	Null	7

TE Codes

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

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75713
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOZAPINE","activeIngredients":"CLOZAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOZAPINE","submission":"CLOZAPINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLOZAPINE","submission":"CLOZAPINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLOZAPINE","submission":"CLOZAPINE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLOZAPINE","submission":"CLOZAPINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)