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 "203515."
`
`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
`
`FERRIC CAABOXYMALTOSE
`INJECTABl.E;INTRAVENOUS
`INJECTAFER
`Ull'TPOlD
`750MG IRON/lSML {SOMG IROMIML)
`N203565
`001
`Jul 25, 2013
`Yes
`RX
`
`Return tD Electronic Orange Book Home Page6
`FDA/Center for Drug Evaluation and Research
`Office of Generfc Drugs
`Division of Labelrng and Program Support
`Update Frequency:
`Orange Book Data - MonU!ly
`Generic Drug Product Information & Patient Infonnalfon - Dally
`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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`1. http://www.addthls.com/bookmartc.php?u508=true&v= 152&.usemame=fdamaln
`
`2. http://www.addthls.com/bookmartc.php
`
`3. http://www.fda.gov/def'ault.htm
`4. http://www.fda.gov/Drugs{InfonnatrononDrugs/clef'ault.htm
`5. ../default.cfm
`6. ../default.cfm
`
`Note: If you need help i!lexz55ing inforlTli!ltion in different file formats, see Instruc:tians for Downloading
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`-u~~- ~ 11 rl IJ l5J ..
`
`Ill
`
`Pharmacosmos, Exh. 1012, 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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`1. http://www.addthls.com/bookmi!lrtc.php?u508=true&v= 152&.usemame=fdi!lmaln
`2. http://www.addthls.com/bookmartc.php
`3, http://www.fda.gov/default,htm
`4. http://www.fda.gov/Drugs/InformatlonOnDrugs/default.htm
`s. ../detault.cfm
`6. ../derautt.cfm
`
`Pharmacosmos, Exh. 1012, p. 2
`
`

`

`F'OA. Homel 0tw pmbe_.. Onqe Booir;
`Oranae Book: ADf!:~ Dnia Productll with Th:&-~utlc Eaulvalence Evaluations
`Reeiftl'lrom ql.MllY on Appl No
`PnicU:t Oltl In the OB_Rx llllt.
`Plllfllnt 'Ind Elld~
`
`PmntData
`
`Appl No
`
`N203565
`N203565
`N203565
`
`T
`
`001
`001
`001
`
`Exclualvlty Dala
`
`Prod No
`
`PldllntNo
`
`7612109
`7754702
`8895612
`
`p..,.
`Ellpl111!1on
`Feb5, 2024
`Fe*> 13, '1JJX1
`Jan e. '1IXll
`
`Drug 8u1*11!ce
`c111m
`
`Dru:g Product
`Cllllm
`
`PltllntU•
`Codt
`
`Dell et
`Requen,d
`
`y
`
`y
`y
`y
`
`u • 1iltt 1
`
`u ·1820
`
`Appl No
`
`Prod No
`
`Elll::l•IYlty Code
`
`N2036185
`
`oot
`
`NP
`
`EJd•lwtty Elqllrmlon
`Jiil 25,, 2018
`
`AddlllOllllll lnfDnnlllllon:
`1. Pal.arm in plillahld 14J011111Cdpt 1J1J the Orange Book SUlff end may not ni1lect th& official 1110111pt dale as des en bad In 21 CFR 314.63(d)(I>).
`2. Pal.arm !isled ptar to August 18, 2003 are flaggad With method of use delms arlf 1111 ai.illeable and submitted by the spcnscr. These patarts may not be
`flagged 1Nllll respect to 01her dalma which may apply.
`
`V'tfNI a list d all patent use c:od88
`V'tfNI a list d all ma:bllltty COCl88
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`FOA/Celtertor Drug El/8t.Jatlcri aid R"81l!Ch
`omoe ,_ Genelfc Drugs
`Olvlalon ,_ L&bell~ and Proipm ~
`Upde!e Frecpncy:
`~e Bock oa · Mon4hly
`Genelic 01119 Procl.d l11fo111•1iai1 & Pe!elt lnfCll!!llllion • Dt1'1
`~e Bock Da UpdMed ~ Jlllll.llly 2015
`Pa!eit and Genetic 01119 Proci.ICt Data Last Upda!ed Mill'Ch 08, 2015
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`Llnb on this lll8'C
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`2. http://www.addthla.canlboakmalk.,q,
`3. http://www.fda.gov/deftUt.lim
`4. http:/lwww.fda.govlDrugsllrtcrmalfonOnDrugsldef&IJt.htm
`
`5. . .fdefault.cfrn
`6. . .fdefeult.cfm
`
`Note: H you need help m:cessl~ lnfoima!lon In different tlle foonats, see lnsln.dfons fer DO'lllll'toallng Vlewanl and Playeni.
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`U.S. Food ard Drug Mnlnllltratlcll
`10003 Ntw Hsmpilire Allft)8
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`-/: U.S. Department of Health & Human Services
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`Lina on this pq1e
`1. http://www.addthls.canlboakmalk.~v-1&2&Ull8ITllllTl8'"alri
`2. http://www.addthls.canlboakmalk.,q,
`
`hllp://www 8ClCMlt!e4a tla.pllctipll/cdlt~lllW.cfin?.AlllJl...No=2D3661i&PrccU:Lo=001atale'l=OB_.Rx
`
`1Q
`
`Pharmacosmos, Exh. 1012, p. 3
`
`

`

`31912()15
`
`Ora191 Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`3. http://www.fda.gov/defalJt.htm
`
`4. http://www.fda.gov/Drugs/lnfonnalionOnDn.igs/default. htm
`
`5. ../default. cfm
`
`6. ../default. cfm
`
`htlp:/lwww.accessdatafda.gov/scrir:*Sfcder/ol)ldocs/patexdnew .cfm?Appl_N o=203565&Product_No=001&table1=0B_Rx
`
`212
`
`Pharmacosmos, Exh. 1012, p. 4
`
`