ANDA 214235

CAPLIN

FDA Drug Application

Application #214235

Documents

• Letter: 2021-02-02

Application Sponsors

ANDA 214235

CAPLIN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/50ML (1MG/ML)

0

ARGATROBAN

ARGATROBAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

CAPLIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214235
            [companyName] => CAPLIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"50MG\/50ML (1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-21
        )

)