ANDA 077235

AMPHASTAR PHARMS INC

FDA Drug Application

Application #077235

Application Sponsors

ANDA 077235

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

0

MEDROXYPROGESTERONE ACETATE

MEDROXYPROGESTERONE ACETATE

FDA Submissions

ORIG

1

AP

2017-11-28

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77235
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEDROXYPROGESTERONE ACETATE","submission":"MEDROXYPROGESTERONE ACETATE","actionType":"150MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)