ANDA 215634

XIROMED

FDA Drug Application

Application #215634

Application Sponsors

ANDA 215634

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PROGESTERONE

PROGESTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AO

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215634
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-05
        )

)