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
Skip navigationFDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions
horizonal rule
Dockets Management

Up

2007N-0123: Amlodipine Abbreviated New Drug Application Approvals
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
LET1 03/29/2007 03/29/2007 Federal Government FDA/CDER       pdf  
Signature: Gary J Buehler
C1 03/29/2007 03/29/2007 Drug Industry Pfizer       pdf  
Signature: Peter O Safir
C2 04/04/2007 04/04/2007 Private Industry Daiichi Sankyo, Inc.       pdf
attachment 		 
Signature: Arthur Mann
C3 04/04/2007 04/04/2007 Private Industry Mutual Pharmaceutical Co. Inc.       Table of Contents  
Signature: John Will Ongman
EMC1 04/04/2007 04/04/2007 Private Industry Daiichi Sankyo Inc.       pdf  
Signature: Arthur Mann
EMC2 04/04/2007 04/04/2007 Private Industry Orchid Healthcare (Orchid)       pdf  
Signature: Carolyne R. Hathaway
EMC3 04/04/2007 04/04/2007 Private Industry Medco Health Solutions, Inc, (Medco)       pdf  
Signature: David S. Machlowitz
EMC4 04/04/2007 04/04/2007 Private Industry Apotex, Inc. (formerly TorPharm)       pdf  
Signature: Arthur Y. Tsien
EMC5 04/04/2007 04/04/2007 Private Industry Pfizer       pdf  
Signature: Peter O. Safir
EMC6 04/05/2007 04/05/2007 Private Industry Mylan Pharmaceuticals, Inc.       pdf  
Signature: David J. Harth
EMC7 04/05/2007 04/05/2007 Private Industry TEVA Pharmaceuticals USA       Table of Contents  
Signature: Deborah A. Jaskot
C4 04/05/2007 04/05/2007 Private Industry Caraco Pharmaceutical Laboratories, LTD       pdf  
Signature: Derrick Mann
C5 04/05/2007 04/05/2007 Private Industry Roxane Laboratories       pdf  
Signature: Elizabeth A. Ernst
C6 04/05/2007 04/05/2007 Private Industry Aurobindo Pharma LTD       pdf  
Signature: Prasada Kambham
C7 04/05/2007 04/05/2007 Private Industry Watson Laboratories, Inc.       pdf  
Signature: Ernest Lengle, Ph.D.
EMC8 04/06/2007 04/06/2007 Private Industry Synthon Pharmaceutical Inc.       pdf  
Signature: Michael H. Hinckle
C8 04/13/2007 04/13/2007 Private Industry Zydus Pharmaceuticals (USA) Inc.       pdf  
Signature: G. Srinivas
C9 04/13/2007 04/13/2007 Private Industry Caraco Pharmaceutical Laboratories, LTD       pdf  
Signature: Derrick Mann
LET2 04/13/2007 04/13/2007 Federal Government FDA/CDER to ANDA Applicant       pdf  
  Signature: Gary J. Buehler
C10 05/02/2007 05/02/2007 Private Industry Apotex Inc.       Table of Contents  
Signature: Robert B. Breisblatt
ANS1 05/08/2007 05/08/2007 Federal Government FDA/CDER/OGD to Apotex Corp.       pdf  
  Signature: Gary J. Buehler

Top | Up

Page last updated May 9, 2007 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