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`New Drug Application (NDA): 020121
`Company: GLAXOSMITHKLINE
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020121)
`
`Products on NDA 020121
`
`
`
`CIPLA LTD. EXHIBIT 2002 PAGE 1
`
`CIPLA LTD. EXHIBIT 2002 PAGE 1
`
`
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`FLONASE
`
`Active
`Ingredients
`
`FLUTICASONE
`PROPIONATE
`
`Showing 1 to 1 of 1 entries
`
`Strength
`
`0.05MG/SPRAY **Federal Register
`determination that product was not
`discontinued or withdrawn for safety or
`efficacy reasons**
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`SPRAY,
`METERED;NASAL
`
`Discontinued
`
`None
`
`Yes
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020121
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review Priority;
`Orphan Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`10/19/1994
`
`ORIG-1
`
`Approval
`
`Type 3 - New Dosage
`Form
`
`STANDARD
`
`Notes
`
`Label is not
`available on this
`site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`CIPLA LTD. EXHIBIT 2002 PAGE 2
`
`CIPLA LTD. EXHIBIT 2002 PAGE 2
`
`
`
`Action
`Action
`Date
`Date
`
`Submission
`Submission
`
`01/07/2019
`
`SUPPL-45
`
`Supplement
`Supplement
`Categories
`Categories
`or Approval
`or Approval
`Type
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020121Orig1s045ltr.pdf)
`
`01/23/2015
`
`SUPPL-44
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020121s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020121Orig1s044ltr.pdf)
`
`06/17/2014
`
`SUPPL-43
`
`Manufacturing
`(CMC)
`
`06/17/2014
`
`SUPPL-42
`
`Manufacturing
`(CMC)
`
`06/19/2013
`
`SUPPL-41
`
`Manufacturing
`(CMC)
`
`03/26/2004
`
`SUPPL-30
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20549slr016,20548slr020,20121slr030_flona
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20549slr016,20548slr020,20121slr030ltr
`
`CIPLA LTD. EXHIBIT 2002 PAGE 3
`
`CIPLA LTD. EXHIBIT 2002 PAGE 3
`
`
`
`Action
`Date
`
`Submission
`
`05/01/2003
`
`SUPPL-28
`
`05/23/2002
`
`SUPPL-23
`
`Supplement
`Categories
`or Approval
`Type
`
`Efficacy-Labeling
`Change With
`Clinical Data
`
`Efficacy-New
`Dosing Regimen
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020121s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20121se8-028ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20121s023ltr.pdf)
`
`05/09/2002
`
`SUPPL-20
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf)
`
`05/09/2002
`
`SUPPL-13
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf)
`
`05/09/2002
`
`SUPPL-11
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/NDA20121S011.pdf)
`
`CIPLA LTD. EXHIBIT 2002 PAGE 4
`
`CIPLA LTD. EXHIBIT 2002 PAGE 4
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`05/07/2002
`
`SUPPL-26
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-
`Packaging
`
`03/04/2002
`
`SUPPL-25
`
`Manufacturing
`(CMC)-Control
`
`02/19/2002
`
`SUPPL-24
`
`Manufacturing
`(CMC)-Control
`
`08/03/2001
`
`SUPPL-17
`
`Manufacturing
`(CMC)-Control
`
`07/09/2001
`
`SUPPL-22
`
`Manufacturing
`(CMC)-Control
`
`CIPLA LTD. EXHIBIT 2002 PAGE 5
`
`CIPLA LTD. EXHIBIT 2002 PAGE 5
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`06/25/2001
`
`SUPPL-21
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`09/26/2000
`
`SUPPL-8
`
`Manufacturing
`(CMC)-Control
`
`06/20/2000
`
`SUPPL-16
`
`Manufacturing
`(CMC)
`
`05/17/2000
`
`SUPPL-15
`
`Manufacturing
`(CMC)-Control
`
`02/18/2000
`
`SUPPL-12
`
`Manufacturing
`(CMC)
`
`CIPLA LTD. EXHIBIT 2002 PAGE 6
`
`CIPLA LTD. EXHIBIT 2002 PAGE 6
`
`
`
`Action
`Date
`
`Submission
`
`12/11/1998
`
`SUPPL-9
`
`Supplement
`Categories
`or Approval
`Type
`
`Efficacy-New
`Indication
`
`10/01/1998
`
`SUPPL-10
`
`Labeling
`
`02/18/1998
`
`SUPPL-6
`
`Manufacturing
`(CMC)-Control
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121-S009_FLONASE_prntlbl.pdf
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20121s9ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20121S009_Flonase.cfm)
`
`10/31/1997
`
`SUPPL-5
`
`Efficacy-New
`Indication
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20121.pdf)
`
`12/12/1996
`
`SUPPL-4
`
`Labeling
`
`CIPLA LTD. EXHIBIT 2002 PAGE 7
`
`CIPLA LTD. EXHIBIT 2002 PAGE 7
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories
`or Approval
`Type
`
`03/27/1996
`
`SUPPL-3
`
`Labeling
`
`08/01/1995
`
`SUPPL-2
`
`Manufacturing
`(CMC)-Control
`
`Showing 1 to 28 of 28 entries
`
`Labels for NDA 020121
`
`
`
`CIPLA LTD. EXHIBIT 2002 PAGE 8
`
`CIPLA LTD. EXHIBIT 2002 PAGE 8
`
`