ANDA 076219

UPSHER SMITH LABS

FDA Drug Application

Application #076219

Documents

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

Application Sponsors

ANDA 076219

UPSHER SMITH LABS

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2003-06-19
LABELING; Labeling	SUPPL	2	AP	2004-12-29
LABELING; Labeling	SUPPL	3	AP	2005-09-26
LABELING; Labeling	SUPPL	5	AP	2006-07-21
LABELING; Labeling	SUPPL	10	AP	2007-11-05
LABELING; Labeling	SUPPL	12	AP	2007-11-05
LABELING; Labeling	SUPPL	14	AP	2012-05-01
LABELING; Labeling	SUPPL	15	AP	2012-05-01
LABELING; Labeling	SUPPL	20	AP	2013-08-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-02-25	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-02-25	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-08-04	STANDARD
LABELING; Labeling	SUPPL	27	AP	2021-08-04	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-09-23	STANDARD

Submissions Property Types

SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	20	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	15
SUPPL	28	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76219
            [companyName] => UPSHER SMITH LABS
            [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"}]
            [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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)