ANDA 076186

UPSHER SMITH LABS

FDA Drug Application

Application #076186

Application Sponsors

ANDA 076186

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-12-16
LABELING; Labeling	SUPPL	9	AP	2007-11-19
LABELING; Labeling	SUPPL	10	AP	2009-02-09
LABELING; Labeling	SUPPL	12	AP	2009-06-04
LABELING; Labeling	SUPPL	18	AP	2012-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2017-12-13	UNKNOWN

Submissions Property Types

SUPPL	18	Null	15
SUPPL	22	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76186
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)