ANDA 206888

GLAND PHARMA LTD

FDA Drug Application

Application #206888

Documents

• Letter: 2020-12-01

Application Sponsors

ANDA 206888

GLAND PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE; INJECTION

12.5MG/260ML

0

TIROFIBAN HYDROCHLORIDE

TIROFIBAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-01-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206888
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIROFIBAN HYDROCHLORIDE","activeIngredients":"TIROFIBAN HYDROCHLORIDE","strength":"12.5MG\/260ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/31\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-31
        )

)