ANDA 213928

LEADING PHARMA LLC

FDA Drug Application

Application #213928

Application Sponsors

ANDA 213928

LEADING PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	500MG	0	AMINOCAPROIC ACID	AMINOCAPROIC ACID
002	TABLET;ORAL	1GM	0	AMINOCAPROIC ACID	AMINOCAPROIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213928
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-12
        )

)