ANDA 040760

HIKMA PHARMS

FDA Drug Application

Application #040760

Documents

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

Application Sponsors

ANDA 040760

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE

FDA Submissions

	ORIG	1	AP	2007-08-15
LABELING; Labeling	SUPPL	6	AP	2020-04-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-04-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-10-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-07-18	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40760
            [companyName] => HIKMA PHARMS
            [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-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/040760Orig1s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROXYCHLOROQUINE SULFATE","submission":"HYDROXYCHLOROQUINE SULFATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-04-01
        )

)