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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Search results from the "OB_Rx" table for query on "204592."
`
`DICLOFENAC
`CAPSULE;ORAL
`ZORVOLEX
`IROKO PHARMS LLC
`18MG
`N204592
`001
`Oct 18, 2013
`No
`RX
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`Active Ingredient:
`DICLOFENAC
`Dosage Form;Route:
`CAPSULE;ORAL
`Proprietary Name:
`ZORVOLEX
`Applicant:
`IROKO PHARMS LLC
`Strength:
`35MG
`Application Number:
`N204592
`Product Number:
`002
`Approval Date:
`Oct 18, 2013
`Reference Listed Drug
`Yes
`RX/OTC/DISCN:
`RX
`TE Code:
`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 September 2015
`Patent and Generic Drug Product Data Last Updated November 02, 2015
`
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`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. ../default.cfm
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`
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`LUPIN EX. 1029
`Lupin v. iCeutica
`US Patent No. 9,017,721
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`11/2/2015
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
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`11/2/2015
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Patent and Exclusivity Search Results from query on Appl No 204592 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N204592
`N204592
`N204592
`
`001
`001
`001
`
`8679544
`8999387
`9017721
`
`Patent
`Expiration
`Apr 23, 2030
`Apr 23, 2030
`Apr 23, 2030
`
`Exclusivity Data
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`
`Y
`
`U 55
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N204592
`N204592
`
`001
`001
`
`NP
`I 692
`
`Exclusivity Expiration
`Oct 18, 2016
`Aug 22, 2017
`
`Additional information:
`1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
`2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be
`flagged with respect to other claims which may apply.
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`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 September 2015
`Patent and Generic Drug Product Data Last Updated November 02, 2015
`
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`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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`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1888INFOFDA (18884636332)
`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
`
`
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`2. http://www.addthis.com/bookmark.php
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