Drug application

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

Drugs@FDA ANDA 208436 · TEVA PHARMS USA INC

Key facts

Drug name AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Active ingredients AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE
Application type ANDA
Application number 208436
Company TEVA PHARMS USA INC
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 Apr 8, 2025

At a glance

  • 1–9 Submissions
  • 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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