ANDA 076541

SUN PHARM INDS INC

FDA Drug Application

Application #076541

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 076541

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	15MG	0	MIRTAZAPINE	MIRTAZAPINE
002	TABLET;ORAL	30MG	0	MIRTAZAPINE	MIRTAZAPINE
003	TABLET;ORAL	45MG	0	MIRTAZAPINE	MIRTAZAPINE
004	TABLET;ORAL	7.5MG	0	MIRTAZAPINE	MIRTAZAPINE

FDA Submissions

	ORIG	1	AP	2004-04-22
LABELING; Labeling	SUPPL	2	AP	2005-03-10
LABELING; Labeling	SUPPL	3	AP	2005-03-10
LABELING; Labeling	SUPPL	4	AP	2005-07-12
LABELING; Labeling	SUPPL	5	AP	2005-07-12
LABELING; Labeling	SUPPL	8	AP	2007-03-26
LABELING; Labeling	SUPPL	9	AP	2007-10-29
LABELING; Labeling	SUPPL	10	AP	2007-11-07
LABELING; Labeling	SUPPL	11	AP	2008-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-06-17	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2016-10-17	STANDARD
LABELING; Labeling	SUPPL	21	AP	2016-10-17	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-11-20	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-09-25	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-09-25	STANDARD
LABELING; Labeling	SUPPL	27	AP	2022-09-15	STANDARD

Submissions Property Types

SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	15
SUPPL	26	Null	15
SUPPL	27	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] => 76541
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIRTAZAPINE","activeIngredients":"MIRTAZAPINE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"45MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MIRTAZAPINE","submission":"MIRTAZAPINE","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)