ANDA 090920

AM REGENT

FDA Drug Application

Application #090920

Application Sponsors

ANDA 090920

AM REGENT

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

ORIG

1

AP

2010-01-19

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AO
002	Prescription	AO

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90920
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"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":"ESTRADIOL VALERATE","submission":"ESTRADIOL VALERATE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESTRADIOL VALERATE","submission":"ESTRADIOL VALERATE","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)