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Details for New Drug Application (NDA): 202236

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NDA 202236 describes DYMISTA, which is a drug marketed by Meda Pharms and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DYMISTA profile page.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

Summary for NDA: 202236

Meda Pharms
azelastine hydrochloride; fluticasone propionate

Suppliers and Packaging for NDA: 202236

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals Inc. 0037-0245 0037-0245-06 1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals Inc. 0037-0245 0037-0245-23 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
Approval Date:May 1, 2012TE:RLD:Yes
Patent:8,168,620Patent Expiration:Feb 24, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,163,723Patent Expiration:Aug 29, 2023Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Feb 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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