ANDA 214391

AJANTA PHARMA LTD

FDA Drug Application

Application #214391

Application Sponsors

ANDA 214391

AJANTA PHARMA LTD

Marketing Status

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

Application Products

001	CAPSULE;ORAL	100MG	0	DROXIDOPA	DROXIDOPA
002	CAPSULE;ORAL	200MG	0	DROXIDOPA	DROXIDOPA
003	CAPSULE;ORAL	300MG	0	DROXIDOPA	DROXIDOPA

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214391
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-18
        )

)