ANDA 210723

AM REGENT

FDA Drug Application

Application #210723

Documents

• Letter: 2018-07-06

Application Sponsors

ANDA 210723

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

250MG/ML (250MG/ML)

0

HYDROXYPROGESTERONE CAPROATE

HYDROXYPROGESTERONE CAPROATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210723
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYPROGESTERONE CAPROATE","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"250MG\/ML (250MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210723Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-21
        )

)