Drug application

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)

Drugs@FDA ANDA 203433 · HIKMA PHARMS

Key facts

Drug name FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Active ingredients FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE
Application type ANDA
Application number 203433
Company HIKMA PHARMS
Dosage forms POWDER, INHALATION
Strength 0.1MG/INH;EQ 0.05MG BASE/INH
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 17, 2020

At a glance

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

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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 · Source date:

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