ANDA 078033

UPSHER SMITH LABS

FDA Drug Application

Application #078033

Application Sponsors

ANDA 078033

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

OXANDROLONE

OXANDROLONE

FDA Submissions

	ORIG	1	AP	2007-03-22
LABELING; Labeling	SUPPL	4	AP	2009-04-15
	ORIG	22	AP	2007-03-22

Submissions Property Types

SUPPL

22

Null

0

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78033
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXANDROLONE","activeIngredients":"OXANDROLONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXANDROLONE","submission":"OXANDROLONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)