DR REDDYS LABS LTD FDA Approval ANDA 078997

ANDA 078997

DR REDDYS LABS LTD

FDA Drug Application

Application #078997

Documents

Review2012-06-22

Application Sponsors

ANDA 078997DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 150MG BASE0IBANDRONATE SODIUMIBANDRONATE SODIUM

FDA Submissions

ORIG1AP2012-04-30
LABELING; LabelingSUPPL2AP2015-07-15STANDARD
LABELING; LabelingSUPPL3AP2015-07-15STANDARD
LABELING; LabelingSUPPL4AP2020-06-19STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL3Null15
SUPPL4Null15

TE Codes

001PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78997
            [companyName] => DR REDDYS LABS LTD
            [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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