ANDA 212780

AMNEAL PHARMS LLC

FDA Drug Application

Application #212780

Documents

• Letter: 2019-10-03

Application Sponsors

ANDA 212780

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

1.25GM/5ML

0

AMINOCAPROIC ACID

AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212780
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"1.25GM\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212780Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-23
        )

)