ANDA 072219

AUROLIFE PHARMA LLC

FDA Drug Application

Application #072219

Application Sponsors

ANDA 072219

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

3.75MG

0

CLORAZEPATE DIPOTASSIUM

CLORAZEPATE DIPOTASSIUM

FDA Submissions

	ORIG	1	AP	1988-08-26
LABELING; Labeling	SUPPL	4	AP	1999-08-24
LABELING; Labeling	SUPPL	10	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL

10

Null

15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72219
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLORAZEPATE DIPOTASSIUM","activeIngredients":"CLORAZEPATE DIPOTASSIUM","strength":"3.75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLORAZEPATE DIPOTASSIUM","submission":"CLORAZEPATE DIPOTASSIUM","actionType":"3.75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)