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`FDA Home3W4 QranaLBoeks
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`eraggsoeae'sasetavseaBrestfiragacgeuaiiiiisrsaeia i59u'va'ence Eva'uatwns
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`Appl No
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`Prod No
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`Active Ingredient
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`Patent No
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`Patent Expire Drug
`Substance
`Ciaim
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`Drug Product Patent Use
`Claim
`Code
`
`Delist
`Requested
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`N021044
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`ND2‘I044
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`N021044
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`N021044
`
`001
`
`002
`
`003
`
`004
`
`Additional information:
`
`HYDROMORPHONE
`HYDROCHLORIDE
`
`5953452
`
`Nov 4‘ 2014
`
`rHYDROMORPl-IONE
`HYDROCHLORIDE
`
`5958452
`
`Nov 4‘ 2014
`
`HYDROMORPHONE
`HYDROCHLORIDE
`
`5958452
`
`Nov 4‘ 2014
`
`HYDROMORPHONE
`HYDROCHLORIDE
`
`5955452
`
`Nov 4, 2014
`
`Y
`
`Y
`
`‘1‘
`
`Y
`
`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
`Return to Electronic Orange Book Home Page6
`FDA/Centerfor Drug Evaluation and Research
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`Patent and Generic Drug Product Data Last Updated October 22, 2014
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`F A Home3
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`rug at bases4 Ora g Book5
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`.
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`grargegoofi: Approved Drug Products With Therapeutic Equwalence
`gaarc aFL‘E‘fiS from the "OB_Disc" table for query on "021044."
`
`.
`
`.
`
`Active Ingredient:
`
`Dosage Form;Route:
`
`Proprietary Name:
`
`Applicant:
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`RX/OTC/DISCN:
`
`HYDROMORPHONE HYDROCHLORIDE
`
`CAPSULE, EXTENDED RELEASE;ORAL
`
`PALLADONE
`
`PURDUE PHARMA LP
`12MG
`
`N021044
`001
`
`Sep, 24, 2004
`DISCN
`
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`Dosage Form;Route:
`
`Proprietary Name:
`Applicant:
`Strength:
`
`Application Number:
`Product Number:
`
`HYDROMORPHONE HYDROCHLORIDE
`CAPSULE, EXTENDED RELEASE;ORAL
`
`PALLADONE
`PURDUE PHARMA LP
`16MG
`
`N021044
`002
`
`Sep, 24, 2004
`Approval Date:
`DISCN
`RX/OTC/DISCN:
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`
`Application Number:
`Product Number:
`
`HYDROMORPHONE HYDROCHLORIDE
`CAPSULE, EXTENDED RELEASE;ORAL
`PALLADONE
`PURDUE PHARMA LP
`24MG
`
`N021044
`003
`
`Sep, 24, 2004
`Approval Date:
`DISCN
`RX/OTC/DISCN:
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`Dosage Form;Route:
`
`Proprietary Name:
`Applicant:
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`HYDROMORPHONE HYDROCHLORIDE
`CAPSULE, EXTENDED RELEASE;ORAL
`
`PALLADONE
`PURDUE PHARMA LP
`32MG
`
`N021044
`004
`
`Sep, 24, 2004
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?App1_No=021044&TA...
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`10/22/2014
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`DISCN
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`Update Frequency:
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`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
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`"0319mm: W a n @514 as
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`For Government For Press
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