ANDA 075483

WOCKHARDT LTD

FDA Drug Application

Application #075483

Documents

• Letter: 2000-08-22

Application Sponsors

ANDA 075483

WOCKHARDT LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
002	TABLET;ORAL	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	2000-08-22
LABELING; Labeling	SUPPL	3	AP	2004-09-23
LABELING; Labeling	SUPPL	10	AP	2008-08-14
LABELING; Labeling	SUPPL	14	AP	2015-09-01
LABELING; Labeling	SUPPL	15	AP	2015-09-01	STANDARD

Submissions Property Types

SUPPL	14	Null	15
SUPPL	15	Null	7

TE Codes

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

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75483
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)