ANDA 074584

UPSHER SMITH LABS

FDA Drug Application

Application #074584

Application Sponsors

ANDA 074584

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	0	BACLOFEN	BACLOFEN
002	TABLET;ORAL	20MG	0	BACLOFEN	BACLOFEN

FDA Submissions

	ORIG	1	AP	1996-08-19
LABELING; Labeling	SUPPL	4	AP	2005-09-20
LABELING; Labeling	SUPPL	18	AP	2011-06-17

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74584
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)