WOCKHARDT LTD FDA Approval ANDA 074532

ANDA 074532

WOCKHARDT LTD

FDA Drug Application

Application #074532

Application Sponsors

ANDA 074532WOCKHARDT LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL12.5MG0CAPTOPRILCAPTOPRIL
002TABLET;ORAL25MG0CAPTOPRILCAPTOPRIL
003TABLET;ORAL50MG0CAPTOPRILCAPTOPRIL
004TABLET;ORAL100MG0CAPTOPRILCAPTOPRIL

FDA Submissions

ORIG1AP1997-03-28
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-04-22
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-04-22
LABELING; LabelingSUPPL7AP2015-01-20STANDARD
LABELING; LabelingSUPPL8AP2015-10-30STANDARD
LABELING; LabelingSUPPL10AP2020-03-11STANDARD
LABELING; LabelingSUPPL12AP2020-03-11STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL7Null15
SUPPL8Null15
SUPPL10Null15
SUPPL12Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

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
        )

)

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