ANDA 040150

INVATECH

FDA Drug Application

Application #040150

Documents

• Label: 2020-04-08
• Letter: 2020-04-08

Application Sponsors

ANDA 040150

INVATECH

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE

FDA Submissions

	ORIG	1	AP	1996-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-03-20
LABELING; Labeling	SUPPL	7	AP	2020-04-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	15

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40150
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/01\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/040150Orig1s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROXYCHLOROQUINE SULFATE","submission":"HYDROXYCHLOROQUINE SULFATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-04-01
        )

)