ANDA 201570

APOTEX INC

FDA Drug Application

Application #201570

Application Sponsors

ANDA 201570

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 300MG BASE

0

ABACAVIR SULFATE

ABACAVIR SULFATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-12-17
LABELING; Labeling	SUPPL	2	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-01-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-01-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201570
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE","activeIngredients":"ABACAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/26\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/26\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/26\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/31\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-01-26
        )

)