DR REDDYS LABS LTD FDA Approval ANDA 091650

ANDA 091650

DR REDDYS LABS LTD

FDA Drug Application

Application #091650

Documents

Review2021-01-07

Application Sponsors

ANDA 091650DR REDDYS LABS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 10MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
002TABLET;ORALEQ 20MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM
003TABLET;ORALEQ 40MG BASE0ATORVASTATIN CALCIUMATORVASTATIN CALCIUM

FDA Submissions

ORIG1AP2012-07-17
LABELING; LabelingSUPPL2AP2012-12-29STANDARD
LABELING; LabelingSUPPL5AP2014-11-05STANDARD
LABELING; LabelingSUPPL7AP2016-02-24STANDARD
LABELING; LabelingSUPPL11AP2019-10-22STANDARD
LABELING; LabelingSUPPL13AP2019-10-22STANDARD
LABELING; LabelingSUPPL15AP2019-10-22STANDARD
LABELING; LabelingSUPPL17AP2020-10-13STANDARD
LABELING; LabelingSUPPL18AP2021-05-18STANDARD
LABELING; LabelingSUPPL19AP2021-05-18STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL5Null15
SUPPL7Null15
SUPPL11Null15
SUPPL13Null15
SUPPL15Null15
SUPPL17Null15
SUPPL18Null15
SUPPL19Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91650
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATORVASTATIN CALCIUM","activeIngredients":"ATORVASTATIN CALCIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATORVASTATIN CALCIUM","submission":"ATORVASTATIN CALCIUM","actionType":"EQ 40MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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