ANDA 203723

HIKMA

FDA Drug Application

Application #203723

Application Sponsors

ANDA 203723

HIKMA

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	10MG/ML	0	ESTRADIOL VALERATE	ESTRADIOL VALERATE
002	INJECTABLE;INJECTION	20MG/ML	0	ESTRADIOL VALERATE	ESTRADIOL VALERATE
003	INJECTABLE;INJECTION	40MG/ML	0	ESTRADIOL VALERATE	ESTRADIOL VALERATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-21

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AO
002	Prescription	AO
003	Prescription	AO

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203723
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESTRADIOL VALERATE","activeIngredients":"ESTRADIOL VALERATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-21
        )

)