ANDA 213806

EMCURE PHARMS LTD

FDA Drug Application

Application #213806

Application Sponsors

ANDA 213806

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

300MG/VIAL

0

PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213806
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTAMIDINE ISETHIONATE","activeIngredients":"PENTAMIDINE ISETHIONATE","strength":"300MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-07
        )

)