|
2007N-0389: Granisetron Hydrochloride Injection and 180-day Generic Drug Exclusivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
|
| LET1
|
| 10/11/2007
|
| 10/11/2007
|
| Private Industry
|
| Teva Parenteral Medicines,
Inc.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Marc Goshko
|
|
|
|
|
| LET2
|
| 10/16/2007
|
| 10/16/2007
|
| Federal Government
|
| FDA/CDER/OGD
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Gary J. Buehler
|
|
|
|
|
| C1
|
| 10/25/2007
|
| 10/25/2007
|
| Private Industry
|
| WINSTON & STRAWN
LLP
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| James F. Hurst
|
|
|
|
|
| EC1
|
| 10/31/2007
|
| 10/25/2007
|
| Drug Industry
|
| Baxter Healthcare
Corporation
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| Polen, Tom
|
|
|
|
|
| C2
|
| 10/31/2007
|
| 10/31/2007
|
| Private Industry
|
| A. Tsien
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| C3
|
| 11/01/2007
|
| 11/01/2007
|
| Individual Consumer
|
| D. G. Adams
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LET3
|
| 1/23/2008
|
| 1/23/2008
|
| Federal Government
|
| D. G. Adams
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| Gary J. Buehler
|
|
|
|
Top | Up
Page last updated:
January 23, 2008
|
