`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug Products
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`EVENT• OVERVIEW.PROCESS&APPLN0• 020573l
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`EVENT=OVERVIEW.PROCESS&APPLN0=020573l
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`New Drug Application (NDA): 020573
`Company: HORIZON PHARMA INC
`
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`Products on NDA 020573
`
`csv
`
`Excel
`
`
`J
`
`v
`
`Drug
`Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`BUPHENYL
`
`SODIUM
`PHENYLBUTYRATE
`
`Showing 1 to 1 of 1 entries
`
`3GMfTEASPOONFUL
`
`POWDER; ORAL
`
`Prescription
`
`AB
`
`Yes
`
`Yes
`
`Approval Date(s) and History. Letters. Labels. Reviews for NDA 020573
`
`Original Approvals or Tentative Approvals
`
`I CSV I Excel I Print
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`04/30/1996
`
`ORIG-1
`
`Approval
`
`Type 1 -New Molecular
`Entity
`
`PRIORITY; Orphan
`
`Notes
`
`Label is not
`available on this
`site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`https://www.accessdata.fda.gov/scripts/cder/daflindex.cfm?event=overview.process&AppiNo=020573
`
`1/2
`
`Par Pharmaceutical, Inc. Ex. 1030
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 1 of 2
`
`
`
`6/29/2018
`
`Drugs@FDA: FDA Approved Drug Prcx:Jucts
`
`CSV Excel
`
`
`Action
`Date
`
`Submission
`
`08/05/2013
`
`SUPPL-19
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`03/31/2009
`
`SUPPL-15
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata. fda.gov/drugsatfda_docs/label/2009/020572s016,020573s0151bl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020572s016,020573s0151tr.pdf)
`
`10/09/1998
`
`SUPPL-2
`
`Labeling
`
`11/07/1996
`
`SUPPL-1
`
`Manufacturing
`(CMC)-Control
`
`Showing 1 to 4 of 4 entries
`
`Labels for NDA 020573
`
`Therapeutic Eguivalents for NDA 020573
`
`https://www.accessdata.fda.gov/scripts/cder/daflinclex.cfm?event=overview.process&AppiNo=020573
`
`212
`
`Par Pharmaceutical, Inc. Ex. 1030
`Par v. Horizon, IPR of Patent No. 9,561,197
`Page 2 of 2
`
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