ANDA 211229

AMNEAL

FDA Drug Application

Application #211229

Application Sponsors

ANDA 211229

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/VIAL

0

CARMUSTINE

CARMUSTINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211229
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARMUSTINE","activeIngredients":"CARMUSTINE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-16
        )

)