ANDA 070589

UPSHER SMITH LABS

FDA Drug Application

Application #070589

Application Sponsors

ANDA 070589

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-05-05
LABELING; Labeling	SUPPL	4	AP	1988-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-03-27
LABELING; Labeling	SUPPL	6	AP	1991-02-26
LABELING; Labeling	SUPPL	7	AP	1991-02-26
LABELING; Labeling	SUPPL	8	AP	1991-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1995-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-10-18
LABELING; Labeling	SUPPL	20	AP	1996-10-18
LABELING; Labeling	SUPPL	21	AP	1997-12-16
LABELING; Labeling	SUPPL	24	AP	2003-03-26
LABELING; Labeling	SUPPL	26	AP	2003-10-31
LABELING; Labeling	SUPPL	29	AP	2004-11-17
LABELING; Labeling	SUPPL	37	AP	2007-11-19
LABELING; Labeling	SUPPL	38	AP	2009-02-09
LABELING; Labeling	SUPPL	40	AP	2009-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2014-07-28
LABELING; Labeling	SUPPL	45	AP	2012-01-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	44	Null	15
SUPPL	45	Null	15

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70589
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)