ANDA 213342

ACCORD HLTHCARE

FDA Drug Application

Application #213342

Application Sponsors

ANDA 213342

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	200MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
002	TABLET;ORAL	100MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
003	TABLET;ORAL	300MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE
004	TABLET;ORAL	400MG	0	HYDROXYCHLOROQUINE SULFATE	HYDROXYCHLOROQUINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213342
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYCHLOROQUINE SULFATE","activeIngredients":"HYDROXYCHLOROQUINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-07
        )

)