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`Drug Approval Package: Dymista (azelastine hydrochloride and fluticasone proprionate) NDA#202236
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`Drug Approval Package
`Dymista (azelastine hydrochloride and fluticasone proprionate) Nasal Spray, 137 mcg/50mcg
`Company: Meda Pharmaceuticals, Inc.
`Application No.: 202236
`Approval Date: 05/01/2012
`Persons with disabi lities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
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`• Approval Letter(s) (PDF)
`• Summary Review (PDF)
`• Officer/Employee List (PDF)
`• Cross Discipline Team Leader Review (PDF)
`• Printed Labeling (PDF)
`• Medical Review(s) (PDF)
`• Microbiology Review (PDF)
`• Chemistry Review(s) (PDF)
`• Pharmacology Review(s) (PDF)
`• Proprietary Name Review(s) (PDF)
`• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
`• Statistical Review (PDF)
`• Other Review(s) (PDF)
`• Administrative Document(s) & Correspondence (PDF)
`
`Date created: May 6, 2013
`Updated: July 26, 2013
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`CIP2067
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
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`Drug Approval Package: Dymista (azelastine hydrochloride and fluticasone proprionate) NDA#202236
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