ANDA 083607

IMPAX LABS

FDA Drug Application

Application #083607

Documents

• Review: 2003-08-05

Application Sponsors

ANDA 083607

IMPAX LABS

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

ORIG

1

AP

1977-08-19

Submissions Property Types

ORIG

1

Null

0

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83607
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)