ANDA 211629

ANI PHARMS INC

FDA Drug Application

Application #211629

Application Sponsors

ANDA 211629

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

UNKNOWN

UNKNOWN

0

AMINOCAPROIC ACID

AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211629
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-14
        )

)