ANDA 203232

MACLEODS PHARMS LTD

FDA Drug Application

Application #203232

Documents

• Letter: 2014-08-07

Application Sponsors

ANDA 203232

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

0

TENOFOVIR DISOPROXIL FUMARATE

TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-01-26
UNKNOWN;	ORIG	2	AP	2018-01-26	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-01-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-01-07	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2022-08-31	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	11	Null	15
SUPPL	16	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203232
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203232Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/07\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/07\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/07\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-07
        )

)