ANI PHARMS INC FDA Approval ANDA 080142

ANDA 080142

ANI PHARMS INC

FDA Drug Application

Application #080142

Application Sponsors

ANDA 080142ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG0SULFISOXAZOLESULFISOXAZOLE

FDA Submissions

ORIG1AP1974-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL58AP1992-08-14
MANUF (CMC); Manufacturing (CMC)SUPPL59AP1993-01-05
LABELING; LabelingSUPPL60AP1996-04-17
MANUF (CMC); Manufacturing (CMC)SUPPL61AP1997-05-30
MANUF (CMC); Manufacturing (CMC)SUPPL62AP1998-12-09
MANUF (CMC); Manufacturing (CMC)SUPPL63AP1999-08-20
MANUF (CMC); Manufacturing (CMC)SUPPL64AP1999-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL65AP1999-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL66AP1999-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL67AP1999-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL68AP1999-11-23
MANUF (CMC); Manufacturing (CMC)SUPPL69AP2000-01-28
MANUF (CMC); Manufacturing (CMC)SUPPL71AP2002-03-12
MANUF (CMC); Manufacturing (CMC)SUPPL72AP2002-07-29

Submissions Property Types

SUPPL58Null0
SUPPL59Null0
SUPPL61Null0
SUPPL62Null0
SUPPL63Null0
SUPPL64Null0
SUPPL65Null0
SUPPL66Null0
SUPPL67Null0
SUPPL68Null0
SUPPL69Null0
SUPPL71Null0
SUPPL72Null0

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80142
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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