ANDA 204990

LUPIN LTD

FDA Drug Application

Application #204990

Documents

• Letter: 2016-11-22
• Letter: 2017-03-30

Application Sponsors

ANDA 204990

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE;300MG

0

ABACAVIR SULFATE AND LAMIVUDINE

ABACAVIR SULFATE; LAMIVUDINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2020-02-24	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	31
SUPPL	7	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204990
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE AND LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE; LAMIVUDINE","strength":"EQ 600MG BASE;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204990Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204990Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)