ANDA 211086

EXELA PHARMA

FDA Drug Application

Application #211086

Application Sponsors

ANDA 211086

EXELA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

ERYTHROMYCIN LACTOBIONATE

ERYTHROMYCIN LACTOBIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211086
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN LACTOBIONATE","activeIngredients":"ERYTHROMYCIN LACTOBIONATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-17
        )

)