ANDA 091665

PAR STERILE PRODUCTS

FDA Drug Application

Application #091665

Application Sponsors

ANDA 091665

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MG/2.5ML (100MG/ML)

0

ARGATROBAN

ARGATROBAN

FDA Submissions

ORIG

1

AP

2014-06-30

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91665
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"250MG\/2.5ML (100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARGATROBAN","submission":"ARGATROBAN","actionType":"250MG\/2.5ML (100MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)