ANDA 075514

WOCKHARDT BIO AG

FDA Drug Application

Application #075514

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 075514

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-08-29
LABELING; Labeling	SUPPL	2	AP	2005-08-31
LABELING; Labeling	SUPPL	3	AP	2006-03-02
LABELING; Labeling	SUPPL	5	AP	2007-05-09
LABELING; Labeling	SUPPL	6	AP	2007-10-10
LABELING; Labeling	SUPPL	7	AP	2008-06-03
LABELING; Labeling	SUPPL	8	AP	2008-06-03
LABELING; Labeling	SUPPL	9	AP	2009-08-21
LABELING; Labeling	SUPPL	11	AP	2010-05-06
LABELING; Labeling	SUPPL	12	AP	2014-12-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-12-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-08-30	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-09-21	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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