ANDA 083559

BELMORA LLC

FDA Drug Application

Application #083559

Application Sponsors

ANDA 083559

BELMORA LLC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

3%

0

MEPIVACAINE HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1973-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-10-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-11-03
LABELING; Labeling	SUPPL	20	AP	1989-11-29
LABELING; Labeling	SUPPL	21	AP	1990-10-25
LABELING; Labeling	SUPPL	22	AP	1993-03-04
LABELING; Labeling	SUPPL	23	AP	1994-08-10

Submissions Property Types

SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

BELMORA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83559
            [companyName] => BELMORA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPIVACAINE HYDROCHLORIDE","activeIngredients":"MEPIVACAINE HYDROCHLORIDE","strength":"3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPIVACAINE HYDROCHLORIDE","submission":"MEPIVACAINE HYDROCHLORIDE","actionType":"3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)