ANDA 073263

UPSHER SMITH LABS

FDA Drug Application

Application #073263

Application Sponsors

ANDA 073263

UPSHER SMITH LABS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;ORAL	EQ 4GM RESIN/PACKET	0	PREVALITE	CHOLESTYRAMINE
002	POWDER;ORAL	EQ 4GM RESIN/SCOOPFUL	0	PREVALITE	CHOLESTYRAMINE

FDA Submissions

	ORIG	1	AP	1996-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-10-30
LABELING; Labeling	SUPPL	5	AP	1997-10-30
LABELING; Labeling	SUPPL	7	AP	1998-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-08-27
LABELING; Labeling	SUPPL	10	AP	1999-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-12-19

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73263
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREVALITE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREVALITE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/SCOOPFUL","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREVALITE","submission":"CHOLESTYRAMINE","actionType":"EQ 4GM RESIN\/PACKET","submissionClassification":"POWDER;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PREVALITE","submission":"CHOLESTYRAMINE","actionType":"EQ 4GM RESIN\/SCOOPFUL","submissionClassification":"POWDER;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)