ANDA 089853

AUROLIFE PHARMA LLC

FDA Drug Application

Application #089853

Application Sponsors

ANDA 089853

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

CHLORZOXAZONE

CHLORZOXAZONE

FDA Submissions

	ORIG	1	AP	1988-05-04
LABELING; Labeling	SUPPL	2	AP	1989-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-12-30
LABELING; Labeling	SUPPL	4	AP	1996-06-05

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0

TE Codes

001

Prescription

AA

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89853
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORZOXAZONE","submission":"CHLORZOXAZONE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)