ANDA 074703

WOCKHARDT BIO AG

FDA Drug Application

Application #074703

Documents

• Letter: 2011-05-17
• Review: 2011-12-02
• Review: 2011-12-02
• Letter: 2011-05-17
• Medication Guide: 2011-02-18

Application Sponsors

ANDA 074703

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-10-31
LABELING; Labeling	SUPPL	2	AP	2001-12-20
LABELING; Labeling	SUPPL	3	AP	2002-07-12
LABELING; Labeling	SUPPL	4	AP	2003-08-18
LABELING; Labeling	SUPPL	5	AP	2012-05-16
LABELING; Labeling	SUPPL	6	AP	2009-06-30
LABELING; Labeling	SUPPL	7	AP	2009-09-15
LABELING; Labeling	SUPPL	8	AP	2011-02-17
LABELING; Labeling	SUPPL	9	AP	2011-02-15
LABELING; Labeling	SUPPL	10	AP	2014-04-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	10	Null	8

TE Codes

001

Prescription

AA

CDER Filings

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