| Up
2005P-0008:
Food and Drug Administration not approve ANDAs for simvastatin tablets,
5mg,10mg, 20mg and 40mg until IPI's 180-day exclusivity under ANDA
No. 76-052 has expired
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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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| CP1
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| 01/06/2005
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| 01/07/2005
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| Drug Industry
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| Ivax Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Monte R. Browder
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| ACK1
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| 01/07/2005
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| 01/07/2005
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| Federal Government
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| HFA-305 to Ivax Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| EMC1
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| 04/05/2005
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| 04/05/2005
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| Federal Government
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| Federal Trade Commission
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| pdf
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| Signature:
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| Donald S Clark
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| RC1
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| 04/12/2005
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| 04/11/2005
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| Private Industry
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| IVAX Corporation
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| pdf
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| Signature:
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| Monte R Browder
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| C1
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| 04/06/2005
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| 04/06/2005
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| Federal Government
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| US Federal Trade Commission
(FTC)
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| pdf
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| Signature:
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| Donald S. Clark
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| RC2
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| 05/10/2005
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| 05/06/2005
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| Private Industry
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| IVAX Corporation
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| pdf
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| Signature:
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| Monte R. Browder
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| C2
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| 05/20/2005
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| 05/20/2005
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| Drug Industry
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| Ranbaxy Laboratories,
Inc. (Ranbaxy)
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| Table
of Contents
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| Signature:
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| Kate C. Beardsley
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| CR1
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| 05/25/2005
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| 05/24/2005
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| Private Industry
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| IVAX Pharmaceuticals,
Inc.
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| pdf
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| See CP 1(Att. B)
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| Signature:
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| Monte R. Browder
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| C3
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| 06/09/2005
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| 06/09/2005
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| Private Industry
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| Teva Pharmaceuticals
USA
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| pdf
Exhibit A,
Exhibit B
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| Signature:
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| Deborah A. Jaskot, M.S., RAC
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| C4
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| 07/01/2005
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| 07/01/2005
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| Drug Industry
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| Ranbaxy Laboratories,
Inc. (Ranbaxy)
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| pdf
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| Signature:
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| Kate C. Beardsley and Carmen
M. Sh
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| LET1
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| 07/05/2005
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| 07/05/2005
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| Federal Government
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| HFD-005 to Ivax Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Jane A. Axelrad
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| RC3
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| 07/12/2005
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| 07/11/2005
|
| Drug Industry
|
| Ivax Pharmaceuticals,
Inc.
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|
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|
|
| pdf
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|
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| Signature:
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| Monte R. Browder
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| LET2
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| 10/24/2005
|
| 10/21/2005
|
| Drug Industry
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| Teva Pharmaceuticals
USA
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| pdf
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|
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| Signature:
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| Deborah A. Jaskot, M.S., RAC
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| PDN1
|
| 10/26/2005
|
| 10/26/2005
|
| Federal Government
|
| HFD-001 to Ivax Pharmaceuticals,
Inc.
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|
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| pdf
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| Signature:
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| Steven K. Galson, M.D., MPH
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| LET3
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| 06/26/2006
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| 06/26/2006
|
| Federal Government
|
| FDA/CDER to Ivax Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Steven K. Galson, M.D., M.P.H.
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|
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Page last updated
July 27, 2006
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