FDA Hormt PM llmted OrJNc 8oQk5
`Oranae Book: Approved Drua Products with Therapeutic Equivalence Evaluations
`S..rc1' rault» from U.. "OB_RX" tabl• for q•ry on "022180."
`
`Active Ingredient:
`Dosage Form ;Route:
`P~prletery Nllme:
`ApJlllCClnt:
`St~ngth:
`ApJlllCCltlon Number:
`Product Number:
`Approval Date:
`~~nai Listed Drug
`RlfJ'OTCIOISO\I:
`'TECode:
`Patent end Exdusivity Info for lllis product: View
`
`FER.UMOXYTOI..
`SOUJnON;INmAVENOUS
`FERAHEME
`AMAG PHARM$ INC
`EQ 510MG IROH/17ML (EQ JOMG IRON/ML)
`N022180
`001
`Jun 30, 2009
`Yes
`RX
`
`Return tD Electronic Orange Book Home Page6
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`Office of Generfc Drugs
`Division of Labelrng and Program Support
`Update Frequency:
`Orange Book Data - MonU!ly
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`Oran,e Book Dllt21 Updated Through January 2015
`Pabent and Generic Drug Product Daf21 l.J!lst Updated March 06, 2015
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`3. http://www.fda.gov/def'ault.htm
`
`4. http://www.fda.gov/DrugsJinfonnatrononDrugs/def'ault.htm
`5. ../default.cfm
`6. ../default.cfm
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`-u~~- ~ 11 rl IJ l5J ..
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`Ill
`
`Pharmacosmos, Exh. 1015, p. 1
`
`

`
`CJrwvio-\:P !Od~--Ti.._.oEcPil - - (cid:173)
`For Government For Press
`Combination Produc:ts Advisory C.Ommlttees Sclenc:e & Research RegulaU>ry Information Safety
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`3, http://www.fda.gov/default,htm
`4. http://www.fda.gov/Drugs/InformatlonOnDrugs/default.htm
`s. ../detault.cfm
`6. ../derautt.cfm
`
`Pharmacosmos, Exh. 1015, p. 2
`
`

`
`F'OA. Homel 0tw pmbe_.. Onqe Booir;
`Oranae Book: ADC~ Dnia Productll with TheraDDutlc Eaulvalence Evaluations
`Reeiftl'lrom ql.MllY on Appl No 022t8D PnicU:t Oltl In the OB_Rx llllt.
`Plllfllnt 'Ind Elld~
`
`PmntData
`
`Appl No
`
`T
`
`NO'.l.2180
`NO'.l.2180
`N022U!O
`NO'.l.2180
`N022180
`N022180
`
`001
`001
`001
`001
`001
`001
`
`Prod No
`
`PldllntNo
`
`6599498
`7563479
`7871597
`8501158
`85818&4
`88211947
`
`p..,.
`Ellpl111!1on
`JIJ'l 30, 2023
`Mer8, 2020
`Mer8, 2020
`M•8,2020
`M•8. 20.20
`Mer8, 20.20
`
`Drug 8u1*11!ce
`Clatm
`
`y
`y
`y
`
`y
`
`y
`
`y
`y
`
`Dru:g Product
`Cllllm
`
`PltllntU•
`Codt
`
`Dell et
`Requen,d
`
`-
`
`y +
`y -
`- -
`
`u ·1422
`
`I
`
`Exclualvlty Data
`111tn1 II no unlllqlftd excllllwly fol ltlll llftdLICt,
`AddltlONll lnfllnnlllllon:
`1. PatlllD in pillahld 14J01118C81pt by the Orange Book SUlff and may not l1lflect th& official mcelpt de!e as descrlbad In 21 CFR 314.63(d)(I>).
`2. PatlllD !Isled p1ar to August 18, 2003 are flagged with method of use clalms actr a& ai.itlcable and submitted by the spans er. These patarts may not be
`flagged 1Nlltl 11111pec:t to 01her dalma which may Sjlflly.
`
`V'teNI a !lat ol all patent use c:odB9
`V'teNI a !lat ol all lllKc:UMty cad8ll
`ReClm to Etectnlric Or11'Qe Bod: Hmne P(cid:173)
`FDAlceitertor 01\4) Evat.Jallon and Research
`omoe o1 Genelf c Drugs
`DMalon ol Labeling and Pro!J'afn ~
`Update Frecpney:
`~e Book Data • MonlNy
`Genel!c Drug Procllct lnfClftM1lcn & Pe!erlt lnfcmlllllon- Diiiy
`~e Book Dl!lta Updlbd T'trol.dl JllllJllY 2015
`Pill~ I/Id Genetic Drug Proci.lct Deta Lael Updll!ed March 08, 2015
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`hllp://www 8ClCMlt!e4a tla.pllctipll/cdlt~lllW.cfin?.AlllJl...No=Q22180&PrccU:LNo=001atale'l=OB_.Rx
`
`1Q
`
`Pharmacosmos, Exh. 1015, p. 3
`
`

`
`31912()15
`
`Ora191 Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`3. http://www.fda.gov/defwt.hlm
`
`4. http://www.fda.gov/Drugs/lnformationOnDrugs/default. htm
`
`5. ../default. cfm
`
`6. ../default. cfm
`
`htlp:/lwww.accessdatafda.gov/scrir;U/cder/ol)ldocs/patexdnew .cfm?Appl_N o=022180&Product_No=001&table1=0B_Rx
`
`212
`
`Pharmacosmos, Exh. 1015, p. 4