ANDA 205570

GLAND PHARMA LTD

FDA Drug Application

Application #205570

Documents

• Letter: 2017-06-05

Application Sponsors

ANDA 205570

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

125MG/125ML (1MG/ML)

0

ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205570
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN IN SODIUM CHLORIDE","activeIngredients":"ARGATROBAN","strength":"125MG\/125ML (1MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205570Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-22
        )

)