ANDA 080504

BELMORA LLC

FDA Drug Application

Application #080504

Application Sponsors

ANDA 080504

BELMORA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	2%	0	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE
004	INJECTABLE;INJECTION	0.01MG/ML;2%	0	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
005	INJECTABLE;INJECTION	0.02MG/ML;2%	0	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1972-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1983-10-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1985-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1985-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1987-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1988-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1988-11-08
LABELING; Labeling	SUPPL	33	AP	1989-10-11
LABELING; Labeling	SUPPL	34	AP	1992-10-01

Submissions Property Types

SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

CDER Filings

BELMORA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80504
            [companyName] => BELMORA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.01MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.02MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.01MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.02MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)