ANDA 202501

EMCURE PHARMS LTD

FDA Drug Application

Application #202501

Application Sponsors

ANDA 202501

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 75MG BASE/ML

0

CIDOFOVIR

CIDOFOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2012-07-26

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202501
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIDOFOVIR","activeIngredients":"CIDOFOVIR","strength":"EQ 75MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/26\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/17\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2013-01-17
        )

)