ANDA 077283

GLAND PHARMA LTD

FDA Drug Application

Application #077283

Application Sponsors

ANDA 077283

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3MG/ML

0

ADENOSINE

ADENOSINE

FDA Submissions

	ORIG	1	AP	2007-06-14
LABELING; Labeling	SUPPL	2	AP	2008-01-14
LABELING; Labeling	SUPPL	4	AP	2008-04-14
LABELING; Labeling	SUPPL	6	AP	2009-11-20

Submissions Property Types

SUPPL

6

Null

7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77283
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADENOSINE","activeIngredients":"ADENOSINE","strength":"3MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ADENOSINE","submission":"ADENOSINE","actionType":"3MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)