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FLUTICASONE PROPIONATE

ANDA

FLUTICASONE PROPIONATE | A219060 | RUBICON RESEARCH LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain26 active DMFs5 inactive

22 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDFLUTICASONE PROPIONATE

DMF 154562001

TAPI NL BVFLUTICASONE PROPIONATE

DMF 157452001

CIPLA LTDFLUTICASONE PROPIONATE USP

DMF 157742001

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE

DMF 163342002

STERLING SPAFLUTICASONE PROPIONATE

DMF 164232003

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE USP

DMF 202122007

FARMABIOS SPAFLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)

DMF 204632007

CORAL DRUGS PVT LTDFLUTICASONE PROPIONATE

DMF 218792008

NEWCHEM SPAFLUTICASONE PROPIONATE MICRONIZED

DMF 222362008

AARTI PHARMALABS LTDFLUTICASONE PROPIONATE USP

DMF 229802009

INDUSTRIALE CHIMICA SRLFLUTICASONE PROPIONATE USP

DMF 234272010

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE INHALATION GRADE

DMF 247912011

LUPIN LTDFLUTICASONE PROPIONATE USP

DMF 299752015

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)

DMF 304172016

GLAXOSMITHKLINEFLUTICASONE PROPIONATE

DMF 315342017

CHONGQING HUAPONT PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE INTERMEDIATE

DMF 327832018

GLAXOSMITHKLINE LLCFLUTICASONE PROPIONATE

DMF 329522018

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS III)

DMF 331722018

TIANJIN TIANYAO PHARMACEUTICALS CO LTDFLUTICASONE PROPIONATE USP

DMF 341262019

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE (CRUDE)

DMF 342732019

SHANDONG SIRUI PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE

DMF 353592021

APOTEX INCFLUTICASONE PROPIONATE USP (MICRONIZED)

DMF 353932020

CORAL DRUGS PRIVATE LTDFLUTICASONE PROPIONATE (PROCESS 1)

DMF 363152021

CURIA SPAIN SAUFLUTICASONE PROPIONATE MICRONIZED

DMF 372972022

BREATHGREEN PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE(MICRONIZED AND NON-MICRONIZED)

DMF 387592023

VAMSI LABS LTDFLUTICASONE PROPIONATE USP

DMF 428122025

SCINOPHARM TAIWAN LTDInactiveFLUTICASONE PROPIONATE

DMF 156862001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFLUTICASONE PROPIONATE EP/BP

DMF 175442004

NEULAND LABORATORIES LTDInactiveFLUTICASONE PROPIONATE PH.EUR

DMF 191152006

MYLAN LABORATORIES LTDInactiveFLUTICASONE PROPIONATE USP

DMF 282642014

VAMSI LABS LTDInactiveFLUTICASONE PROPIONATE EP

DMF 402852024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.05MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Aug 15, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Rubicon Research Private Ltd updated its corporate name to Rubicon Research Ltd for fluticasone propionate NDA 219060.

Old: RUBICON RESEARCH PRIVATE LTD

New: RUBICON RESEARCH LTD

MODIFIEDApplicant7/1/2026

Rubicon Research expanded its official registered name on the Orange Book listing for fluticasone propionate (NDA 219060).

Old: RUBICON

New: RUBICON RESEARCH