`
`Drugs@FDA: FDA-Approved Drugs
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`Drugs@FDA: FDA-Approved Drugs
`
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`Home (index.cfm) | Previous Page
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`New Drug Application (NDA): 202236
`Company: MYLAN SPECIALITY LP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS%26VARAPPLNO=202236)
`
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202236Orig1s000SumR.pdf)
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`Products on NDA 202236
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`5/4/2020
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`Drugs@FDA: FDA-Approved Drugs
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`DYMISTA
`
`Active Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`AZELASTINE
`HYDROCHLORIDE;
`FLUTICASONE PROPIONATE
`
`EQ 0.125MG
`BASE/SPRAY;0.05MG/SPRAY
`
`SPRAY,
`METERED;NASAL
`
`Prescription
`
`AB
`
`Yes
`
`Yes
`
`Showing 1 to 1 of 1 entries
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202236
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`05/01/2012
`
`ORIG-1
`
`Approval
`
`Type 4 - New
`Combination
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Showing 1 to 1 of 1 entries
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`Supplements
`
`CSV
`
`Excel
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/2
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/20223
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA-Approved Drugs
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`Action
`Action
`Date
`Date
`
`Submission
`Submission
`
`09/06/2018
`
`SUPPL-10
`
`Supplement
`Supplement
`Categories
`Categories
`or Approval
`or Approval
`Type
`Type
`
`Labeling-
`Package Insert
`
`01/06/2017
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`02/20/2015
`
`SUPPL-8
`
`10/29/2014
`
`SUPPL-7
`
`Efficacy-New
`Patient
`Population
`
`Manufacturing
`(CMC)
`
`06/02/2014
`
`SUPPL-5
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`Note
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202236s010lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202236Orig1s010ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202236s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202236Orig1s008ltr.pdf)
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`5/4/2020
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`Drugs@FDA: FDA-Approved Drugs
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`01/21/2014
`
`SUPPL-4
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)
`
`03/26/2013
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`11/19/2012
`
`SUPPL-2
`
`Manufacturing
`(CMC)
`
`08/10/2012
`
`SUPPL-1
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202236s001lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202236Orig1s001ltr.pdf)
`
`Showing 1 to 9 of 9 entries
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`Labels for NDA 202236
`
`Therapeutic Equivalents for NDA 202236
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
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