UNICHEM FDA Approval ANDA 079106

ANDA 079106

UNICHEM

FDA Drug Application

Application #079106

Application Sponsors

ANDA 079106UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
002TABLET;ORAL5MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
003TABLET;ORAL10MG;6.25MG0BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEBISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

FDA Submissions

ORIG1AP2010-07-28
LABELING; LabelingSUPPL2AP2011-08-29
LABELING; LabelingSUPPL30AP2022-12-01STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL30Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79106
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"2.5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"10MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"2.5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"10MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.