NDA 020707

SANOFI AVENTIS US

FDA Drug Application

Application #020707

Documents

• Letter: 2006-11-22
• Label: 2006-11-22
• Other Important Information from FDA: 2008-01-07
• Letter: 2003-08-28
• Letter: 2010-03-24
• Label: 2010-03-26
• Review: 2010-01-05

Application Sponsors

NDA 020707

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

SKELID

TILUDRONATE DISODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-03-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-08-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2006-11-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-03-19	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

Accessdata Error

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