ANDA 091181

FRESENIUS KABI USA

FDA Drug Application

Application #091181

Application Sponsors

ANDA 091181

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

600MG/VIAL

0

RIFAMPIN

RIFAMPIN

FDA Submissions

ORIG

1

AP

2014-08-21

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91181
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFAMPIN","activeIngredients":"RIFAMPIN","strength":"600MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIFAMPIN","submission":"RIFAMPIN","actionType":"600MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)