ANDA 214117

ACCORD HLTHCARE

FDA Drug Application

Application #214117

Application Sponsors

ANDA 214117

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/VIAL

0

Carmustine

CARMUSTINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214117
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"Carmustine","activeIngredients":"CARMUSTINE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-27
        )

)