ANDA 207645

PHARMASCIENCE INC

FDA Drug Application

Application #207645

Application Sponsors

ANDA 207645

PHARMASCIENCE INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

GANCICLOVIR SODIUM

GANCICLOVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

PHARMASCIENCE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207645
            [companyName] => PHARMASCIENCE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANCICLOVIR SODIUM","activeIngredients":"GANCICLOVIR SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/18\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-18
        )

)