DR REDDYS LABS LTD FDA Approval ANDA 090509

ANDA 090509

DR REDDYS LABS LTD

FDA Drug Application

Application #090509

Application Sponsors

ANDA 090509DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 0.5MG BASE0TACROLIMUSTACROLIMUS
002CAPSULE;ORALEQ 1MG BASE0TACROLIMUSTACROLIMUS
003CAPSULE;ORALEQ 5MG BASE0TACROLIMUSTACROLIMUS

FDA Submissions

ORIG1AP2010-05-12
LABELING; LabelingSUPPL4AP2011-11-28
LABELING; LabelingSUPPL5AP2012-06-27
LABELING; LabelingSUPPL6AP2012-06-27
LABELING; LabelingSUPPL7AP2012-10-12STANDARD
LABELING; LabelingSUPPL8AP2013-05-06STANDARD
LABELING; LabelingSUPPL9AP2015-10-13STANDARD
LABELING; LabelingSUPPL11AP2015-10-13STANDARD
LABELING; LabelingSUPPL16AP2019-10-04STANDARD
LABELING; LabelingSUPPL17AP2019-10-04STANDARD
LABELING; LabelingSUPPL19AP2019-10-04STANDARD
LABELING; LabelingSUPPL22AP2021-04-23STANDARD
LABELING; LabelingSUPPL23AP2021-04-23STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15
SUPPL5Null15
SUPPL6Null15
SUPPL7Null15
SUPPL8Null15
SUPPL9Null7
SUPPL11Null7
SUPPL16Null7
SUPPL17Null7
SUPPL19Null7
SUPPL22Null15
SUPPL23Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90509
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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