ANDA 075178

NOSTRUM LABS INC

FDA Drug Application

Application #075178

Documents

• Letter: 2001-03-23
• Letter: 2004-06-03

Application Sponsors

ANDA 075178

NOSTRUM LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
002	TABLET;ORAL	2.5MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
003	TABLET;ORAL	10MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
004	TABLET;ORAL	20MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE

FDA Submissions

	ORIG	1	AP	2001-03-23
LABELING; Labeling	SUPPL	5	AP	2015-05-01
LABELING; Labeling	SUPPL	8	AP	2008-09-04
LABELING; Labeling	SUPPL	9	AP	2010-08-06
LABELING; Labeling	SUPPL	10	AP	2015-05-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-05-01	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-04-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2018-12-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-12-10	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	31
SUPPL	14	Null	15
SUPPL	15	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75178
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)