ANDA 087872

WOCKHARDT BIO AG

FDA Drug Application

Application #087872

Application Sponsors

ANDA 087872

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

2%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-09-08
LABELING; Labeling	SUPPL	10	AP	1990-04-04
LABELING; Labeling	SUPPL	11	AP	1991-10-10
LABELING; Labeling	SUPPL	12	AP	1994-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-12-02
LABELING; Labeling	SUPPL	17	AP	1996-12-02
LABELING; Labeling	SUPPL	21	AP	2003-01-10
LABELING; Labeling	SUPPL	22	AP	2003-12-18
LABELING; Labeling	SUPPL	23	AP	2014-12-01	STANDARD
LABELING; Labeling	SUPPL	24	AP	2018-11-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	15
SUPPL	24	Null	7

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87872
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)