ANDA 076761

UPSHER SMITH LABS

FDA Drug Application

Application #076761

Documents

• Label: 2006-12-04
• Review: 2007-07-06
• Letter: 2006-12-06

Application Sponsors

ANDA 076761

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

OXANDROLONE

OXANDROLONE

FDA Submissions

	ORIG	1	AP	2006-12-01
LABELING; Labeling	SUPPL	7	AP	2015-08-18

Submissions Property Types

SUPPL

7

Null

7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76761
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXANDROLONE","activeIngredients":"OXANDROLONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/01\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/076761lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXANDROLONE","submission":"OXANDROLONE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-12-01
        )

)