ANDA 078658

HIKMA PHARMS

FDA Drug Application

Application #078658

Application Sponsors

ANDA 078658

HIKMA PHARMS

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET; ORAL	2MG	0	ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE
002	TABLET; ORAL	4MG	0	ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE
003	TABLET; ORAL	8MG	0	ROSIGLITAZONE MALEATE	ROSIGLITAZONE MALEATE

FDA Submissions

ORIG

1

TA

2009-12-08

Submissions Property Types

ORIG

1

Null

0

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78658
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSIGLITAZONE MALEATE","activeIngredients":"ROSIGLITAZONE MALEATE","strength":"2MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ROSIGLITAZONE MALEATE","activeIngredients":"ROSIGLITAZONE MALEATE","strength":"4MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ROSIGLITAZONE MALEATE","activeIngredients":"ROSIGLITAZONE MALEATE","strength":"8MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROSIGLITAZONE MALEATE","submission":"ROSIGLITAZONE MALEATE","actionType":"2MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ROSIGLITAZONE MALEATE","submission":"ROSIGLITAZONE MALEATE","actionType":"4MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ROSIGLITAZONE MALEATE","submission":"ROSIGLITAZONE MALEATE","actionType":"8MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)