ANDA 076514

CHARTWELL RX

FDA Drug Application

Application #076514

Documents

• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22

Application Sponsors

ANDA 076514

CHARTWELL RX

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	2.5MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE
002	TABLET;ORAL	5MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE
003	TABLET;ORAL	10MG	0	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-09-11
LABELING; Labeling	SUPPL	2	AP	2004-07-02
S; Supplement	SUPPL	3	AP	2004-07-02
LABELING; Labeling	SUPPL	9	AP	2010-12-27

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76514
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIDODRINE HYDROCHLORIDE","activeIngredients":"MIDODRINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIDODRINE HYDROCHLORIDE","submission":"MIDODRINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)