ANDA 210189

ZYDUS

FDA Drug Application

Application #210189

Documents

• Review: 2021-09-24

Application Sponsors

ANDA 210189

ZYDUS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

PHYTONADIONE

PHYTONADIONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210189
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-20
        )

)