ANDA 210959

LAURUS LABS LTD

FDA Drug Application

Application #210959

Documents

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

Application Sponsors

ANDA 210959

LAURUS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-04-01	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LAURUS LABS LTD

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(
    [0] => Array
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            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/01\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210959Orig1s001,s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210959Orig1s001,s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210959Orig1s001,s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/01\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210959Orig1s001,s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210959Orig1s001,s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210959Orig1s001,s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210959Orig1s001,s005ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-01
        )

)