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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 "021196."
`
`SODIUM OXYBATE
`SOLUTION;ORAL
`XYREM
`JAZZ PHARMS
`500MG/ML
`N021196
`001
`Jul 17, 2002
`Yes
`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
`Return to Electronic Orange Book Home Page6
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
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`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through April 2014
`Patent and Generic Drug Product Data Last Updated June 11, 2014
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021196&TABLE1=OB_Rx
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=021196&TABLE1=OB_Rx
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`2/2
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`6/4/2014
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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 021196 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`N021196
`
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`
`6780889
`7262219
`7668730
`7765106
`7765107
`7851506
`7851506
`7895059
`8263650
`8263650
`8324275
`8324275
`8457988
`8589182
`8731963
`
`Patent
`Expiration
`Jul 4, 2020
`Jul 4, 2020
`Jun 16, 2024
`Jun 16, 2024
`Jun 16, 2024
`Dec 22, 2019
`Dec 22, 2019
`Dec 17, 2022
`Dec 22, 2019
`Dec 22, 2019
`Dec 22, 2019
`Dec 22, 2019
`Dec 17, 2022
`Dec 17, 2022
`Dec 17, 2022
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`Y
`
`Y
`Y
`
`U - 1110
`U - 1069
`U - 1070
`U - 1101
`U - 1102
`U - 1110
`U - 1101
`U - 1102
`U - 1101
`U - 1102
`U - 1110
`U - 1110
`U - 1110
`
`Exclusivity Data
`There is no unexpired exclusivity for this product.
`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 May 2014
`Patent and Generic Drug Product Data Last Updated June 03, 2014
`
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`3. http://www.fda.gov/default.htm
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`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
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`5. ../default.cfm
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`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
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`Ph. 1-888-INFO-FDA (1-888-463-6332)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`
`1/2
`
`Wockhardt 1021
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`6/4/2014
`Email FDA
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`
`
`
`
`
`
`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:
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`3. http://www.fda.gov/default.htm
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`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
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`5. ../default.cfm
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`6. ../default.cfm
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`
`2/2
`
`Wockhardt 1021