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`Drugs@FDA: FDA Approved Drug Products
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`Drugs@FDA: FDA Approved Drug Products
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`New Drug Application (NDA): 018148
`Company: IVAX RES
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`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=018148)
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`Products on NDA 018148
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Exhibit 1110
`IPR2017-00807
`ARGENTUM
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`2/11/2018
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`Drugs@FDA: FDA Approved Drug Products
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`CSV
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`Excel
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`Drug
`Name
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`Active
`Ingredients
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`Strength
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`Dosage
`Form/Route
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`Marketing
`Status
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`TE Code
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`RLD
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`NASALIDE
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`FLUNISOLIDE
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`0.025MG/SPRAY
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`SPRAY, METERED;NASAL
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`Discontinued
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`None
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`No
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`Showing 1 to 1 of 1 entries
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 018148
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`Original Approvals or Tentative Approvals
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`CSV
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`Excel
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`RS
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`No
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`
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`Action
`Date
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`Submission
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`Action
`Type
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`Submission
`Classification
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`Review Priority;
`Orphan Status
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`Letters, Reviews, Labels,
`Patient Package Insert
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`09/24/1981
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`ORIG-1
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`Approval
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`Type 1 - New
`Molecular Entity
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`PRIORITY
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`Notes
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`Label is not
`available on this
`site.
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`Supplements
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`CSV
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`Action
`Date
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`Submission
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`Supplement
`Categories or
`Approval Type
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`Letters, Reviews, Labels, Patient Package Insert
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`Note
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`000002
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
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`Submission
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`08/23/2002
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`SUPPL-37
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`Supplement
`Categories or
`Approval Type
`
`Manufacturing (CMC)-
`Control
`
`Letters, Reviews, Labels, Patient Package Insert
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`05/09/2002
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`SUPPL-35
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`Labeling
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`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf)
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`05/09/2002
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`SUPPL-30
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`Labeling
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`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf)
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`09/13/2000
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`SUPPL-33
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`Manufacturing (CMC)
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`06/29/2000
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`SUPPL-32
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`Manufacturing (CMC)
`
`Note
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`Label is
`not
`available
`on this
`site.
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`000003
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
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`Submission
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`02/25/1999
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`SUPPL-23
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`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Efficacy-New Dosing
`Regimen
`
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18148s023_nasalide.pdf)
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`02/05/1999
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`SUPPL-29
`
`Manufacturing (CMC)-
`Control
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`04/21/1998
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`SUPPL-28
`
`Manufacturing (CMC)-
`Control
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`08/02/1996
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`SUPPL-27
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`Manufacturing (CMC)
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`08/17/1994
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`SUPPL-24
`
`Manufacturing (CMC)-
`Control
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`Note
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`Label is
`not
`available
`on this
`site.
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`000004
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`2/11/2018
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`Drugs@FDA: FDA Approved Drug Products
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`Letters, Reviews, Labels, Patient Package Insert
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`Action
`Date
`
`Submission
`
`08/05/1994
`
`SUPPL-25
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing (CMC)-
`Control
`
`08/25/1989
`
`SUPPL-14
`
`Manufacturing (CMC)
`
`03/07/1989
`
`SUPPL-22
`
`Manufacturing (CMC)-
`Packaging
`
`02/08/1989
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`SUPPL-21
`
`Labeling
`
`12/23/1987
`
`SUPPL-20
`
`Manufacturing (CMC)-
`Control
`
`Note
`
`Label is
`not
`available
`on this
`site.
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`Label is
`not
`available
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`available
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`Label is
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`000005
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`2/11/2018
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`Drugs@FDA: FDA Approved Drug Products
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`Letters, Reviews, Labels, Patient Package Insert
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`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`09/19/1986
`
`SUPPL-15
`
`Labeling
`
`08/19/1986
`
`SUPPL-11
`
`Manufacturing (CMC)-
`Control
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`04/21/1986
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`SUPPL-7
`
`Manufacturing (CMC)-
`Formulation
`
`09/23/1985
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`SUPPL-12
`
`Labeling
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`07/11/1985
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`SUPPL-13
`
`Labeling
`
`Note
`
`Label is
`not
`available
`on this
`site.
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`Label is
`not
`available
`on this
`site.
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`Label is
`not
`available
`on this
`site.
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`Label is
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`available
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`available
`on this
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`6/8
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`000006
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`2/11/2018
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`Drugs@FDA: FDA Approved Drug Products
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`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`02/21/1985
`
`SUPPL-8
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing (CMC)-
`Control
`
`03/13/1984
`
`SUPPL-10
`
`Labeling
`
`09/09/1983
`
`SUPPL-5
`
`Manufacturing (CMC)
`
`09/09/1983
`
`SUPPL-4
`
`Manufacturing (CMC)
`
`09/09/1983
`
`SUPPL-3
`
`Manufacturing (CMC)
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
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`Label is
`not
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`on this
`site.
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`Label is
`not
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`on this
`site.
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`Label is
`not
`available
`on this
`site.
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`000007
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
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`Supplement
`Categories or
`Approval Type
`
`09/09/1983
`
`SUPPL-2
`
`Manufacturing (CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`08/30/1983
`
`SUPPL-1
`
`Labeling
`
`06/22/1983
`
`SUPPL-6
`
`Labeling
`
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`Note
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`000008
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