ANDA 040657

ZYDUS PHARMS USA INC

FDA Drug Application

Application #040657

Documents

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

Application Sponsors

ANDA 040657

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE

FDA Submissions

	ORIG	1	AP	2007-09-21
LABELING; Labeling	SUPPL	7	AP	2020-03-23	STANDARD

Submissions Property Types

SUPPL

7

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40657
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/040657Orig1s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDROXYCHLOROQUINE SULFATE","submission":"HYDROXYCHLOROQUINE SULFATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-03-23
        )

)