ANDA 207919

EXELA PHARMA SCS LLC

FDA Drug Application

Application #207919

Application Sponsors

ANDA 207919

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/ML

0

ACYCLOVIR SODIUM

ACYCLOVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA SCS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207919
            [companyName] => EXELA PHARMA SCS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR SODIUM","activeIngredients":"ACYCLOVIR SODIUM","strength":"EQ 50MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-17
        )

)