ANDA 078895

UNICHEM

FDA Drug Application

Application #078895

Application Sponsors

ANDA 078895

UNICHEM

Marketing Status

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

Application Products

001	TABLET;ORAL	0.1MG	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE
002	TABLET;ORAL	0.2MG	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE
003	TABLET;ORAL	0.3MG	0	CLONIDINE HYDROCHLORIDE	CLONIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-08-26
LABELING; Labeling	SUPPL	4	AP	2010-09-23
LABELING; Labeling	SUPPL	7	AP	2013-01-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	7	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UNICHEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78895
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLONIDINE HYDROCHLORIDE","submission":"CLONIDINE HYDROCHLORIDE","actionType":"0.3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)