ANDA 070303

UPSHER SMITH LABS

FDA Drug Application

Application #070303

Application Sponsors

ANDA 070303

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG

0

DIAZEPAM

DIAZEPAM

FDA Submissions

	ORIG	1	AP	1985-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-02-23
LABELING; Labeling	SUPPL	6	AP	1988-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-07-08
LABELING; Labeling	SUPPL	8	AP	1993-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-05-09

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70303
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIAZEPAM","submission":"DIAZEPAM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)