ANDA 086724

TARO

FDA Drug Application

Application #086724

Application Sponsors

ANDA 086724

TARO

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

	ORIG	1	AP	1981-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-06-30
LABELING; Labeling	SUPPL	13	AP	1989-09-22
LABELING; Labeling	SUPPL	14	AP	1993-02-16
LABELING; Labeling	SUPPL	20	AP	2006-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2016-09-02	UNKNOWN
LABELING; Labeling	SUPPL	33	AP	2018-11-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2018-11-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	28	Null	7
SUPPL	33	Null	7
SUPPL	35	Null	15

TE Codes

001

Prescription

AT

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86724
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE","submission":"LIDOCAINE","actionType":"5%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)