FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Up

2005P-0322: Immediately Deny Approval of the NDA for INCRE

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 08/11/2005 08/11/2005 Private Industry Insmed Incorporated       Table of Contents  
Signature: Geoffrey Allan, Ph.D.
ACK1 08/11/2005 08/11/2005 Federal Government
HFA-305 to Insmed Incorporated       pdf  
Signature: Lyle D. Jaffe
C1 08/22/2005 08/22/2005 Private Industry Tercica, Inc.       Table of Contents  
Signature: J. Scarlett, MD
RC1 08/26/2005 08/26/2005 Private Industry Insmed Incorporated       01pdf, 02pdf  
Signature: Geoffrey Allan PhD
PDN1 08/31/2005 08/31/2005 Federal Government
HFD-1 to Insmed Incorporated       pdf  
  Signature: Steve Galson MD MPH

Top | Up

Page last updated September 9, 2005 kkhorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management