ANDA 201107

HETERO LABS LTD III

FDA Drug Application

Application #201107

Documents

• Letter: 2012-07-09
• Label: 2016-10-12

Application Sponsors

ANDA 201107

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/ML

0

ABACAVIR SULFATE

ABACAVIR SULFATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2016-09-26
LABELING; Labeling	SUPPL	4	AP	2016-09-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	15

TE Codes

001

Prescription

AA

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201107
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE","activeIngredients":"ABACAVIR SULFATE","strength":"EQ 20MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/26\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201107Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201107Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201107s000TAltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)