ANDA 214533

CAPLIN

FDA Drug Application

Application #214533

Application Sponsors

ANDA 214533

CAPLIN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML

0

LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-09-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

CAPLIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214533
            [companyName] => CAPLIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-07
        )

)