ANDA 091104

AM REGENT

FDA Drug Application

Application #091104

Application Sponsors

ANDA 091104

AM REGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	5MG/10ML (0.5MG/ML)	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-10-08
LABELING; Labeling	SUPPL	2	AP	2011-07-21

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91104
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"5MG\/10ML (0.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"1MG\/10ML (0.1MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"5MG\/10ML (0.5MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)