ANDA 215337

AMNEAL

FDA Drug Application

Application #215337

Application Sponsors

ANDA 215337

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.25MG BASE/ML

0

CARBOPROST TROMETHAMINE

CARBOPROST TROMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215337
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPROST TROMETHAMINE","activeIngredients":"CARBOPROST TROMETHAMINE","strength":"EQ 0.25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-27
        )

)