ANDA 076486

NOSTRUM LABS INC

FDA Drug Application

Application #076486

Application Sponsors

ANDA 076486

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 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	2004-10-27
LABELING; Labeling	SUPPL	3	AP	2007-02-06
LABELING; Labeling	SUPPL	8	AP	2009-04-29
LABELING; Labeling	SUPPL	11	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-07-06	STANDARD

Submissions Property Types

SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76486
            [companyName] => NOSTRUM LABS INC
            [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
        )

)