ANDA 210543

LUPIN LTD

FDA Drug Application

Application #210543

Documents

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

Application Sponsors

ANDA 210543

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-07-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210543
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210543Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210543Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210543Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)