ANDA 212492

AMNEAL

FDA Drug Application

Application #212492

Documents

• Letter: 2019-12-03

Application Sponsors

ANDA 212492

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

AMINOCAPROIC ACID

AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212492
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212492Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-26
        )

)