`
`Page 1 of3
`
`FDA H ome3 Drug Databases4 O range Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`Search results from the "OB_Rx" table for query on "019766."
`
`SIMVASTATIN
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`ZOCOR
`Proprietary Name:
`MERCK
`Applicant:
`5MG
`Strength:
`N019766
`Application Number:
`001
`Product Number:
`Dec 23,1991
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`SIMVASTATIN
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`ZOCOR
`Proprietary Name:
`MERCK
`Applicant:
`10MG
`Strength:
`N019766
`Application Number:
`002
`Product Number:
`Dec 23,1991
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`SIMVASTATIN
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`ZOCOR
`Proprietary Name:
`MERCK
`Applicant:
`20MG
`Strength:
`N019766
`Application Number:
`003
`Product Number:
`Dec 23,1991
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`Active Ingredient:
`Dosage Form;Route:
`
`SIMVASTATIN
`TABLET;ORAL
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019766&TABLE1=OB_Rx
`
`NCI Exhibit 2026
`Page 1 of 5
`
`
`
`Orange Book: Approved DrugProducts with Therapeutic Equivalence Evaluations
`
`Page 2 of3
`
`ZOCOR
`Proprietary Name:
`MERCK
`Applicant:
`40MG
`Strength:
`N019766
`Application Number:
`004
`Product Number:
`Dec 23,1991
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`SIMVASTATIN
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`ZOCOR
`Proprietary Name:
`MERCK
`Applicant:
`80MG
`Strength:
`N019766
`Application Number:
`005
`Product Number:
`Jul 10,1998
`Approval Date:
`Yes
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`Return to Electronic Orange Book Home Page6
`
`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 June 2015
`Patent and Generic Drug Product Data Last Updated July 28,2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5.
`../default.cfm
`6.
`../default.cfm
`
`Note:If you need help accessing information in different file formats,see Instructions for
`Downloading Viewers and Players.
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`Website Policies
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019766&TABLE1=OB_Rx
`
`NCI Exhibit 2026
`Page 2 of 5
`
`
`
`Orange Book: Approved DrugProducts with Therapeutic Equivalence Evaluations
`
`Page 3 of3
`
`U.S. Food and Drug Administration
`10903New Hampshire Avenue
`Silver Spring,MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`For Government For Press
`Combination Products Advisory Committees Science &Research Regulatory Information Safety
`Emergency Preparedness International Programs News &Events Training and Continuing
`Education Inspections/Compliance State &Local Officials Consumers Industry Health
`Professionals FDA Archive
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019766&TABLE1=OB_Rx
`
`NCI Exhibit 2026
`Page 3 of 5
`
`
`
`Orange Book: Approved DrugProducts with Therapeutic Equivalence Evaluations
`
`Page 1 of2
`
`FDA H ome3 Drug Databases4 O range Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`Search results from the "OB_Rx" table for query on "019898."
`
`PRAVASTATIN SODIUM
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`PRAVACHOL
`Proprietary Name:
`BRISTOL MYERS SQUIBB
`Applicant:
`20MG
`Strength:
`N019898
`Application Number:
`003
`Product Number:
`Oct 31,1991
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`PRAVASTATIN SODIUM
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`PRAVACHOL
`Proprietary Name:
`BRISTOL MYERS SQUIBB
`Applicant:
`40MG
`Strength:
`N019898
`Application Number:
`004
`Product Number:
`Mar 22,1993
`Approval Date:
`No
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`PRAVASTATIN SODIUM
`Active Ingredient:
`TABLET;ORAL
`Dosage Form;Route:
`PRAVACHOL
`Proprietary Name:
`BRISTOL MYERS SQUIBB
`Applicant:
`80MG
`Strength:
`N019898
`Application Number:
`008
`Product Number:
`Dec 18,2001
`Approval Date:
`Yes
`Reference Listed Drug
`RX
`RX/OTC/DISCN:
`AB
`TECode:
`Patent and Exclusivity Info for this product:View
`
`Return to Electronic Orange Book Home Page6
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019898&TABLE1=OB_Rx
`
`NCI Exhibit 2026
`Page 4 of 5
`
`
`
`Orange Book: Approved DrugProducts with Therapeutic Equivalence Evaluations
`
`Page 2 of2
`
`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 June 2015
`Patent and Generic Drug Product Data Last Updated July 28,2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5.
`../default.cfm
`6.
`../default.cfm
`
`Note:If you need help accessing information in different file formats,see Instructions for
`Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency
`Website Policies
`
`U.S. Food and Drug Administration
`10903New Hampshire Avenue
`Silver Spring,MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`For Government For Press
`Combination Products Advisory Committees Science &Research Regulatory Information Safety
`Emergency Preparedness International Programs News &Events Training and Continuing
`Education Inspections/Compliance State &Local Officials Consumers Industry Health
`Professionals FDA Archive
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=019898&TABLE1=OB_Rx
`
`NCI Exhibit 2026
`Page 5 of 5