NDC 60505-0953

Azelastine hydrochloride and Fluticasone propionate

Azelastine Hydrochloride And Fluticasone Propionate

Azelastine hydrochloride and Fluticasone propionate is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Azelastine Hydrochloride; Fluticasone Propionate.

Product ID60505-0953_23155c97-c95a-4e82-fc81-2f93e917b803
NDC60505-0953
Product TypeHuman Prescription Drug
Proprietary NameAzelastine hydrochloride and Fluticasone propionate
Generic NameAzelastine Hydrochloride And Fluticasone Propionate
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2020-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA207712
Labeler NameApotex Corp.
Substance NameAZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Active Ingredient Strength137 ug/1; ug/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 60505-0953-3

1 BOTTLE, SPRAY in 1 CARTON (60505-0953-3) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Marketing Start Date2020-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-0953-3 [60505095303]

Azelastine hydrochloride and Fluticasone propionate SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA207712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2020-03-02

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE137 ug/1

OpenFDA Data

SPL SET ID:7bbc6514-bea3-0be0-e673-a8f6069025ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797847
  • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Azelastine hydrochloride and Fluticasone propionate" or generic name "Azelastine Hydrochloride And Fluticasone Propionate"

    NDCBrand NameGeneric Name
    0378-3458Azelastine Hydrochloride and Fluticasone PropionateAzelastine Hydrochloride and Fluticasone Propionate
    45802-066AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionate
    60505-0953Azelastine hydrochloride and Fluticasone propionateAzelastine hydrochloride and Fluticasone propionate
    63629-8612AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEazelastine hydrochloride, fluticasone propionate
    0037-0245DYMISTAAzelastine Hydrochloride and Fluticasone Propionate
    69621-812Ticalastazelastine hydrochloride and fluticasone propionate

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