Drug application

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE)

Drugs@FDA ANDA 208111 · PADAGIS ISRAEL

Key facts

Drug name AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Active ingredients AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE
Application type ANDA
Application number 208111
Company PADAGIS ISRAEL
Dosage forms SPRAY, METERED, NASAL
Strength 0.137MG/SPRAY;0.05MG/SPRAY
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 18, 2021

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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