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2007N-0382:
Ramipril Capsules and 180-day generic drug exclusivity
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| LET1
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| 10/03/2007
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| 10/03/2007
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| Private Industry
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| Hyman, Phelps &
McNamara, P.C
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| Table
of Contents
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| Signature:
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| Robert A. Dormer and Kurt R.
Karst
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| LET2
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| 10/03/2007
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| 10/03/2007
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| Private Industry
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| Lupin Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Carmen M Shepard and Kate C.
Bear
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| LET3
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| 10/03/2007
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| 10/03/2007
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| Federal Government
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| FDA/CDER/OGD
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| pdf
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| Signature:
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| Gary J. Buehler
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| LET4
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| 10/18/2007
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| 10/18/2007
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| Private Industry
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| Sandoz, Inc.
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| pdf
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| Signature:
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| Stepen R. Auten
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| C1
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| 10/19/2007
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| 10/19/2007
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| Private Industry
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| Arent Fox
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| pdf
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| Signature:
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| Wayne H. Matelski
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| C2
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| 10/23/2007
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| 10/23/2007
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| Private Industry
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| Ranbaxy, Inc.
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| pdf
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| Signature:
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| David G. Adams
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| C3
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| 10/23/2007
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| 10/23/2007
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| Private Industry
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| FOLEY & LARDNER
LLP
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| Table
of Contents
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| Signature:
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| David L. Rosen
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| EC3
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| 10/23/2007
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| 10/19/2007
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| Association
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| Pharmaceutical Care
Management Association
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| pdf
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| Signature:
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| Jenkins, Missy
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| EC1
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| 10/23/2007
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| 10/19/2007
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| Private Industry
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| Express Scripts, Inc.
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| pdf
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| Attachments are all
the same;converted one to pdf
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| Signature:
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| Forsyth, Janice
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| EC2
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| 10/23/2007
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| 10/19/2007
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| Drug Industry
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| Apotex
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| htm
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| No attachments
included, see C 5
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| Signature:
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| Giuli, Steve
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| C4
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| 10/24/2007
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| 10/24/2007
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| Private Industry
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| N. Tantillo
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| pdf
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| C5
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| 10/25/2007
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| 10/25/2007
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| Private Industry
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| APOTEX CORP.
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| pdf
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| Signature:
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| Steve Giuli
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| C6
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| 10/26/2007
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| 10/26/2007
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| Private Industry
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| URL MUTUAL
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| pdf
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| Signature:
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| E. Brendan Magrab
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| ACK1
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| 11/14/2007
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| 11/14/2007
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| Private Industry
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| FDA/DDM to Apotex,
Inc.
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| pdf
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| Signature:
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| Gloria Ortega
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| PSA1
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| 11/13/2007
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| 11/13/2007
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| Private Industry
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| Apotex, Inc.
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| Table
of Contents
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| Signature:
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| Shashank Upadhye, Esq
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| ACK2
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| 11/14/2007
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| 11/14/2007
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| Federal Government
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| Number not used
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| C7
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| 11/13/2007
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| 11/13/2007
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| Private Industry
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| KIRKLAND & ELLIS
LLP
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| pdf
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| Signature:
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| Michael D. Shumsky
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| C8
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| 11/27/2007
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| 11/27/2007
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| Private Industry
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| FOLEY & LARDNER
LLP
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|
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| pdf
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|
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| Signature:
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| David L. Rosen
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| LET5
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| 12/10/2007
|
| 12/10/2007
|
| Private Industry
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| FOLEY & LARDNER
LLP
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|
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|
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| pdf
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| Signature:
|
| David L. Rosen
| |
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| LET6
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| 12/29/2008
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| 12/10/2007
|
| Federal Government
|
| FDA/CDER/OGD
|
|
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|
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|
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| pdf
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| Signature:
|
| Gary J. Buehler
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Top
| Up
Page last updated:
December 18, 2007
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