ANDA 076116

UPSHER SMITH LABS

FDA Drug Application

Application #076116

Application Sponsors

ANDA 076116

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG;12.5MG	0	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	10MG;25MG	0	ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE	ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	2001-09-19
LABELING; Labeling	SUPPL	2	AP	2002-09-05
LABELING; Labeling	SUPPL	3	AP	2003-05-29
LABELING; Labeling	SUPPL	7	AP	2011-01-12
LABELING; Labeling	SUPPL	8	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-12-11	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-12-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76116
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","strength":"5MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","strength":"10MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","submission":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","actionType":"5MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE","submission":"ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE","actionType":"10MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)