An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218321
Company: RUBICON RESEARCH

Products on ANDA 218321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218321

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL; 0.05MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	077538	APOTEX
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	078492	CHARTWELL RX
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	076504	HIKMA
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	218321	RUBICON RESEARCH

Top