PRINSTON INC FDA Approval ANDA 040412

ANDA 040412

PRINSTON INC

FDA Drug Application

Application #040412

Documents

Letter2003-04-09

Application Sponsors

ANDA 040412PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL25MG0HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE
002TABLET;ORAL50MG0HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE

FDA Submissions

ORIG1AP2002-03-29
LABELING; LabelingSUPPL11AP2011-12-31
LABELING; LabelingSUPPL23AP2020-08-20STANDARD

Submissions Property Types

SUPPL11Null15
SUPPL23Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40412
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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