ANDA 088254

WOCKHARDT BIO AG

FDA Drug Application

Application #088254

Application Sponsors

ANDA 088254

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

ELIXIR;ORAL

0.5MG/5ML

0

DEXAMETHASONE

DEXAMETHASONE

FDA Submissions

	ORIG	1	AP	1983-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-05-18
LABELING; Labeling	SUPPL	9	AP	1989-12-06
LABELING; Labeling	SUPPL	10	AP	1990-12-31
LABELING; Labeling	SUPPL	11	AP	1993-12-23
LABELING; Labeling	SUPPL	12	AP	1993-12-23
LABELING; Labeling	SUPPL	13	AP	1995-02-03
LABELING; Labeling	SUPPL	15	AP	2015-02-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	7

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88254
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)