ANDA 071918

WOCKHARDT BIO AG

FDA Drug Application

Application #071918

Application Sponsors

ANDA 071918

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

CONCENTRATE;ORAL

EQ 10MG BASE/ML

0

DOXEPIN HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-07-20
LABELING; Labeling	SUPPL	2	AP	1991-04-02
LABELING; Labeling	SUPPL	3	AP	1992-02-12
LABELING; Labeling	SUPPL	4	AP	1993-11-24
LABELING; Labeling	SUPPL	5	AP	1995-08-17
LABELING; Labeling	SUPPL	6	AP	1995-08-17
LABELING; Labeling	SUPPL	7	AP	2001-01-11
LABELING; Labeling	SUPPL	8	AP	2001-11-05
LABELING; Labeling	SUPPL	10	AP	2007-06-26
LABELING; Labeling	SUPPL	12	AP	2008-08-13
LABELING; Labeling	SUPPL	14	AP	2014-07-17	STANDARD

Submissions Property Types

SUPPL

14

Null

7

TE Codes

001

Prescription

AA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71918
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)