ANDA 084850

BELMORA LLC

FDA Drug Application

Application #084850

Application Sponsors

ANDA 084850

BELMORA LLC

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

0.05MG/ML;2%

0

MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1985-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-08-04
LABELING; Labeling	SUPPL	27	AP	1989-10-31
LABELING; Labeling	SUPPL	28	AP	1993-03-24
LABELING; Labeling	SUPPL	29	AP	1993-08-25
LABELING; Labeling	SUPPL	30	AP	1993-12-22
LABELING; Labeling	SUPPL	31	AP	1994-08-10

Submissions Property Types

SUPPL	11	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0

CDER Filings

BELMORA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84850
            [companyName] => BELMORA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPIVACAINE HYDROCHLORIDE W\/ LEVONORDEFRIN","activeIngredients":"LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE","strength":"0.05MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPIVACAINE HYDROCHLORIDE W\/ LEVONORDEFRIN","submission":"LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE","actionType":"0.05MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)