Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202236

DYMISTA (AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE)
EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY Marketing Status: Prescription

Active Ingredient: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Proprietary Name: DYMISTA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202236
Product Number: 001
Approval Date: May 1, 2012
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
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