ANDA 214596

CIPLA USA INC.

FDA Drug Application

Application #214596

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 214596

CIPLA USA INC.

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	1MG/0.5ML	0	PHYTONADIONE	PHYTONADIONE
002	INJECTABLE;INJECTION	10MG/ML	0	PHYTONADIONE	PHYTONADIONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB2
002	Prescription	AB2

CDER Filings

CIPLA USA INC.

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214596
            [companyName] => CIPLA USA INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"1MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHYTONADIONE","activeIngredients":"PHYTONADIONE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-22
        )

)