`
`httpdlwwwmoessdatzifdsigovlscriptslccladdaffindex.cfm?event=overvie...
`
`Drugs@FDA: FDA Approved
`Drug Products
`
`
`
`f SHARE HI1'PS:IIVlVIVl.FACEDO0K.OOWSHAR$ISHARE|lPI'lP?U:H1TP lIVlVIVl.ACOA'l’A.FDA.GOV
`ISCRI‘1SICDEWDAFflII)EX.CFI?EVENT=OVERWEW.PROCESS&APPLlIk0flE
`
`: FDA APPROVED DRUG PRODUCT
`g TVIEET Il'l'IPS:II'IWl'ITER.OOIlIfl'BlTI'lWETI7'I'EXT=DR
`SIURl=HTI'P:IIVlVlVl.AOCE$DA‘II.FDA.GOVISCRlPl'SICDERIDAFIINDEX.CFI?EVBlT=0VERVIEVlPROCES
`
`
`
`[I1 LII(ED|N HTIPSdMWVlUII(EDIMCOWSHAREARTlCLE?II=TRUElURLdI"PfllWWWAOCESSDATA
`
`.FDLGWISCflW§CDEVMFIIDH.CFI?HEm=WERWEW.PROCE$&AWLNO=0mflflTHLE£RU§
`QFDA: FDA APPROVED DRUG RCEmA)
`
`Q PIN lT[l'ITl'PS IMWW.PIlTERESIO0WHWCREATEIBUTfONflURbHTTPJMWWAxESSDA'Il.HJA.G0
`VISCRIPTSICEWDAFflflJEX.CFI?EVBlT=OVERVIEW.PRO§$&APM.NO=02l572&DESCRl"l'DN:DRUGS
`E: FDA APPROVED DRIKE PROIIJCISI
`
`i I
`
`EIAIL (flILTO:?SUBJEC'l'=$UGS@FDA: FDA APPROVE) DRUG PRODUC'I'S&BODV=HTl'P:IIVlVlVl.AC
`CESSDATA.FDA.GOVISCRI"l3ICDERIDAFfllIJEX.CFI1EVENT=OVERVEVl.PROC&APPLll0d)%a
`
`31'
`
`Home (index.ctm) | Previous Pag
`
`New Drug Application (NDA): 020572
`company: HORIZON PHARMA INC
`Drug Name(s):
`- BUPHENYL (SODIUM PHENYLBUTYRATE)
`
`- JAIL (IAlL'I'0:?SlBJEC"I'=WU§@FDA: FDA APPROVE DRUG PRODUC'I'S&BODY=l'I'l1'P IIVIVIVLAC
`CESSDATA.FDA.GOVISCRPT§CDEWDEflNEX.CFI?HBfl=OVERVIHl.PROCESS%$VARAPM.lD:Mfi
`L11
`
`Produgts on NDA 020572
`
`A
`
`roval Date s and Histo
`
`Letters Labels Reviews for NDA 020572
`
`as
`
`Original Approvals or Tentative Approvals
`
`csVExoeIPrint
`
`lof3
`
`719/2017 ll:36 AM
`
`Page 1 of 3
`
`Horizon Exhibit 2045
`
`Lupin v. Horizon
`IPR2016—00829
`
`
`
`Drugs@FDA: FDA Approved Drug Products
`
`httpzllwww.accessdatafda.govlscriptslcdcrldaflincbx.cfm?cvent=overvie...
`
`Review
`
`Priority;
`Orphan
`Submission
`Classification Status
`
`PRIORITY
`Type 3- New
`Dosage Form ;
`Orphan
`
`Letters,
`Reviews,
`Labels,
`
`Patient
`Package
`Insert
`
`Note:
`
`Label
`not
`avail:
`on th
`site.
`
`Action
`Date
`
`Action
`Submission Type
`
`05/13/1996 ORIG-1
`
`Approval
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSVExcelPrin1
`
`Action
`
`Date
`
`Submission
`
`Letters, Reviews, Labels,
`
`Submission Classification
`
`Patient Package Insert
`
`No
`
`10/06/2015
`
`SUPPL-21
`
`08/02/2013
`
`SUPPL-20
`
`Manufacturing
`(cMc)
`
`Manufacturing
`(CMC)
`
`03/31/2009
`
`SUPPL-16
`
`Labeling
`
`10/09/1 998
`
`SUPPL-2
`
`Labeling
`
`11/07/1996
`
`SUPPL-1
`
`Manufacturing
`(CMC)-control
`
`Showing 1 to 5 of 5 entries
`
`Label (PDF)
`(http://www.accessdata.fda.gov
`/drugsatfda_docsIlabel
`/20091020572501 6,020573501 5IbI. pdf)
`Letter (PDF)
`(http://www.accessdata.fda.gov
`/drugsatfda_docs/appletter
`/2009/020572s016,020573s015Itr.pdf)
`
`Labels for NDA 020572
`
`v
`
`2of3
`
`Page 2 of 3
`
`2/9/2017 11:36 AM
`
`
`
`Drugs@FDA: FDA Approved Drug Products
`
`httpzllwww.accessdatafda.govlscriptslcdcddaflinthx.cfm?cvent=overvie...
`
`Theragutic Eguivalents for NDA 020572
`
`v
`
`3 of3
`
`Page 3 of 3
`
`2/9/2017 11:36 AM
`
`