ANDA 080429

BIONPHARMA INC

FDA Drug Application

Application #080429

Application Sponsors

ANDA 080429

BIONPHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

JELLY;TOPICAL

2%

0

ANESTACON

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1974-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-06-05
LABELING; Labeling	SUPPL	14	AP	1991-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-01-16

Submissions Property Types

SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80429
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANESTACON","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"JELLY;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANESTACON","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"2%","submissionClassification":"JELLY;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)