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Case 1:07-cv-00821-JJF
Document 12-2
Filed 02/15/2008
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Exhibit A
Orange Book Detail Record Search Case 1:07-cv-00821-JJF
Document 12-2
Filed 02/15/2008
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Search results from the "OB_Rx" table for query on "076526."
Active Ingredient: Dosage Form;Route: Proprietary Name: Applicant: Strength: Application Number: Product Number: Approval Date: Reference Listed Drug RX/OTC/DISCN: TE Code:
FLUOROURACIL SOLUTION; TOPICAL FLUOROURACIL TARO 2% 076526 001 Nov 5, 2003 No RX
AT
Patent and Exclusivity Info for this product: View Active Ingredient: Dosage Form;Route: Proprietary Name: Applicant: Strength: Application Number: Product Number: Approval Date: Reference Listed Drug RX/OTC/DISCN: TE Code: FLUOROURACIL SOLUTION; TOPICAL FLUOROURACIL TARO 5% 076526 002 Nov 5, 2003 No RX
AT
Patent and Exclusivity Info for this product: View
Return to Electronic Orange Book Home Page
FDA/Center for Drug Evaluation and Research Office of Generic Drugs Division of Labeling and Program Support Update Frequency: Orange Book Data - Monthly Generic Drug Product Information & Patent Information - Daily Orange Book Data Updated Through January, 2008 Patent and Generic Drug Product Data Last Updated: February 15, 2008
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=076526&TAB... 2/15/2008
Case 1:07-cv-00821-JJF
Document 12-2
Filed 02/15/2008
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Exhibit B
Dockets: 2004P-0557: ANDA for a Generic Version of Efudex Cream(fluorouracil) Cream Page 1 of 2 Case 1:07-cv-00821-JJF Document 12-2 Filed 02/15/2008 Page 4 of 7
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2004P-0557: ANDA for a Generic Version of Efudex Cream(fluorouracil) Cream
Document Received # Date CP1 Filed Date Submitter Code Submitter Valeant Pharmaceuticals International Signature:Dr. Kim D. Lamon,Dr. Grag J. Kricorian FR FR Comment DatePage Date Files Table of Contents Remarks
12/21/200412/22/2004Drug Industry
ACK1
HFA-305 to Valeant 12/21/200412/21/2004Federal GovernmentPharmaceuticals International Signature:Lyle D. Jaffe HFD-5 to Valeant 06/17/200506/17/2005Federal GovernmentPharmaceuticals International Signature:Jane A Axelrad 09/16/200509/16/2005Private Industry Rothwell Figg Ernst & Manbeck PC Signature:Stephen Lieberman Valeant Pharmaceuticals International Signature:Brian R McCormick Valeant Pharmaceuticals International Signature:Kim D. Lamon, M.D., PhD and Greg J Rothwell Figg Ernst & Manbeck Signature:Steven
pdf
LET1
pdf
C1
pdf
LET2
10/07/200510/07/2005Drug Industry
pdf
RC1
10/21/200510/21/2005Drug Industry
pdf Tabs
C2
01/03/200601/03/2006Private Industry
Table of Contents
http://www.fda.gov/ohrms/dockets/dockets/04p0557/04p0557.htm
2/14/2008
Dockets: 2004P-0557: ANDA for a Generic Version of Efudex Cream(fluorouracil) Cream Page 2 of 2 Case 1:07-cv-00821-JJF Document 12-2 Filed 02/15/2008 Page 5 of 7
Lieberman LET3 01/13/200601/13/2006Private Industry Hogan & Hartson, LLP Signature:David M. Fox Valeant Pharmaceuticals International Signature:Greg J. Kricorian, M.D. pdf
RC2
04/03/200604/03/2006Drug Industry
Table of Contents
OB1 C3
04/28/200604/24/2006Individual D. Lowe Consumer 05/05/200605/05/2006Private Industry Rothwell Figg Ernst & Manbeck Signature:Steven Lieberman Valeant Pharmaceuticals International Signature:David M. Fox Valeant Pharmaceuticals International Signature:Greg J. Kricorian, M.D. pdf Appendices
LET4
05/31/200605/31/2006Drug Industry
pdf
RC3
07/13/200607/13/2006Drug Industry
pdf Tab 1
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http://www.fda.gov/ohrms/dockets/dockets/04p0557/04p0557.htm
2/14/2008
Case 1:07-cv-00821-JJF
Document 12-2
Filed 02/15/2008
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Exhibit C
FDA's Mission Statement Case 1:07-cv-00821-JJF
Document 12-2
Filed 02/15/2008
Page 1 of 1 Page 7 of 7
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
FDA's Mission Statement
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility FDA Website Management Staff
http://www.fda.gov/opacom/morechoices/mission.html
2/14/2008
Free Opening Brief in Support - District Court of Delaware - Delaware
| File Size: | 950.3 kB |
| Pages: | 30 |
| Date: | September 6, 2008 |
| File Format: | |
| State: | Delaware |
| Category: | District Court of Delaware |
| Author: | unknown |
| Word Count: | 1,089 Words, 6,535 Characters |
| Page Size: | 613 x 792 pts |
| URL |
https://www.findforms.com/pdf_files/ded/39471/12.pdf |
| Download Opening Brief in Support - District Court of Delaware ( 950.3 kB) |
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