ANDA 202127

LUPIN LTD

FDA Drug Application

Application #202127

Documents

• Letter: 2015-07-14

Application Sponsors

ANDA 202127

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

667MG

0

CALCIUM ACETATE

CALCIUM ACETATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-07-09

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202127
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM ACETATE","activeIngredients":"CALCIUM ACETATE","strength":"667MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202127Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-09
        )

)