ANDA 074532

WOCKHARDT LTD

FDA Drug Application

Application #074532

Application Sponsors

ANDA 074532

WOCKHARDT LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	12.5MG	0	CAPTOPRIL	CAPTOPRIL
002	TABLET;ORAL	25MG	0	CAPTOPRIL	CAPTOPRIL
003	TABLET;ORAL	50MG	0	CAPTOPRIL	CAPTOPRIL
004	TABLET;ORAL	100MG	0	CAPTOPRIL	CAPTOPRIL

FDA Submissions

	ORIG	1	AP	1997-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-04-22
LABELING; Labeling	SUPPL	7	AP	2015-01-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-03-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-03-11	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	15

TE Codes

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

CDER Filings

WOCKHARDT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74532
            [companyName] => WOCKHARDT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CAPTOPRIL","activeIngredients":"CAPTOPRIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CAPTOPRIL","submission":"CAPTOPRIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)