WATSON LABS TEVA FDA Approval ANDA 079003

ANDA 079003

WATSON LABS TEVA

FDA Drug Application

Application #079003

Documents

Review2012-05-09
Review2012-04-13

Application Sponsors

ANDA 079003WATSON LABS TEVA

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 150MG BASE0IBANDRONATE SODIUMIBANDRONATE SODIUM

FDA Submissions

ORIG1AP2012-03-20
LABELING; LabelingSUPPL2AP2017-01-24STANDARD
LABELING; LabelingSUPPL7AP2017-01-24STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL7Null7

TE Codes

001PrescriptionAB

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79003
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBANDRONATE SODIUM","submission":"IBANDRONATE SODIUM","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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