NDA 022359

BAXTER HLTHCARE CORP

FDA Drug Application

Application #022359

Documents

• Letter: 2010-08-09

Application Sponsors

NDA 022359

BAXTER HLTHCARE CORP

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE; INJECTION

250MG/250ML

0

ARGATROBAN

ARGATROBAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2010-07-28

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22359
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"250MG\/250ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARGATROBAN","submission":"ARGATROBAN","actionType":"250MG\/250ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)