ANDA 211688

ACCORD HLTHCARE

FDA Drug Application

Application #211688

Application Sponsors

ANDA 211688

ACCORD HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	OINTMENT;TOPICAL	0.03%	0	TACROLIMUS	TACROLIMUS
002	OINTMENT;TOPICAL	0.1%	0	TACROLIMUS	TACROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211688
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"0.03%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-31
        )

)