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`Drugs@FDA: FDA Approved Drug Products
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`Home (index.cfm) I Previous Page
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`New Drug Application (NDA): 020572
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`Company: HORIZON PHARMA INC
`Drug Name(s):
`•BUPHENYL (SODIUM PHENYLBUTYRATE)
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`CESSDATA.FDA.GOV/SCRJPTSICDER/DAF/INDEX.CFM?EVENT:OVERVIEW.PROCESS%26VARAPPLN0:0205
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`Products on NDA 020572
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020572 A
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`Original Approvals or Tentative Approvals
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`Horizon Exhibit 2038
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`Par v. Horizon
`IPR2017-01767
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`Drugs@FDA: FDA Approved Drug Products
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`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overvie...
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`Action
`Date
`
`Action
`Submission Type
`
`Review
`Priority;
`Orphan
`Submission
`Classification Status
`
`Letters,
`Reviews,
`Labels,
`Patient
`Package
`Insert
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`05/13/1996 ORIG-1
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`PRIORITY
`Approval Type3-New
`Dosage Form ;
`Orphan
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`Note:
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`Label
`not
`avail:
`on th
`site.
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`Supplements
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`CSVExcelPrint
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`Action
`Date
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`Submission
`Submission Classification
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`Letters, Reviews, Labels,
`Patient Package Insert
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`Ni
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`Label (PDF)
`(http://www.accessdata.fda.gov
`/drugsatfda_docs/label
`/2009/020572s016,020573s015Ibl.pdf)
`Letter (PDF)
`(http://www.accessdata.fda.gov
`/drugsatfda_docs/appletter
`/2009/020572s016,020573s015ltr.pdf)
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`10/06/2015
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`SUPPL-21
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`08/02/2013
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`SUPPL-20
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`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)
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`03/31/2009
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`SUPPL-16
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`Labeling
`
`10/09/1998
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`SUPPL-2
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`Labeling
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`11/07/1996
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`SUPPL-1
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`Manufacturing
`(CMC)-Control
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`Labels for NDA 020572
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`2 of 3
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`Drugs@FDA: FDA Approved Drug Products
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`Therapeutic Equivalents for NDA 020572
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