ANDA 090096

CHARTWELL RX

FDA Drug Application

Application #090096

Documents

• Other Important Information from FDA: 2008-11-13

Application Sponsors

ANDA 090096

CHARTWELL RX

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG;7.5MG	0	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
002	TABLET;ORAL	12.5MG;15MG	0	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
003	TABLET;ORAL	25MG;15MG	0	MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-09-25
LABELING; Labeling	SUPPL	2	AP	2013-12-13
LABELING; Labeling	SUPPL	3	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90096
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"12.5MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"12.5MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"25MG;15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"12.5MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"12.5MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"25MG;15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)